Quantitative Assessment of Endoscope Tip Angulation Performance in New Endoscopes: A Cross-Sectional Quality Improvement Study

Background: Endoscope tip angulation is a key determinant of procedural maneuverability, yet routine quantitative assessment is not standardized, and data are limited on how quickly new endoscopes fall below manufacturer-specified performance benchmarks during routine use. The aim of this study was to evaluate tip angulation performance in new, apparently functional endoscopes after a period of clinical use and to characterize the prevalence and pattern of below-tolerance findings by scope type. Methods: We performed a quality improvement project to evaluate the tip angulation of newly issued endoscopes within nine months of clinical use. In phase 1, endoscopes were systematically assessed by 3 trained physicians using a reference chart. In phase 2, a company representative independently evaluated endoscopes using a calibrated instrument. Results: 32 new endoscopes (18 colonoscopes and 14 gastroscopes) were evaluated. All scopes were used for approximately 9 months. The mean procedure count for colonoscopes was 185.6 (± 12.5, range 162-201) and for gastroscopes was 150.6 (± 12.0, range 133-166). 5 out of 18 colonoscopes (27.8%) fell below manufacturer tolerance thresholds for maximal tip deflection in at least one direction. All 14 gastroscopes met manufacturer tolerance thresholds in all four directions. Conclusions: This cross-sectional study found that a notable proportion of new colonoscopes fell below manufacturer tolerance thresholds after approximately nine months of clinical use, despite being considered apparently functional. These findings highlight the need for periodic, objective assessment of tip angulation, even in endoscopes without apparent defects. Longitudinal studies are needed to establish deterioration trajectories and inform maintenance guidelines.

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Publication Details

Journal
Endoscopy International Open
Published
2026-05-16
DOI
https://doi.org/10.1055/a-2877-9452
Primary Topic
Medical Device Sterilization and Disinfection
Type
article
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article

Quantitative Assessment of Endoscope Tip Angulation Performance in New Endoscopes: A Cross-Sectional Quality Improvement Study

Saksham Kohli, Daksh Ahluwalia, Seema Gandhi, Vikram Kotwal et al.
Endoscopy International Open
Medical Device Sterilization and Disinfection
article

Quantitative Assessment of Endoscope Tip Angulation Performance in New Endoscopes: A Cross-Sectional Quality Improvement Study

Saksham Kohli, Daksh Ahluwalia, Seema Gandhi, Vikram Kotwal, Mihir Shah, Shalini Atluri, Eric Zhao
article en

Abstract

Background: Endoscope tip angulation is a key determinant of procedural maneuverability, yet routine quantitative assessment is not standardized, and data are limited on how quickly new endoscopes fall below manufacturer-specified performance benchmarks during routine use. The aim of this study was to evaluate tip angulation performance in new, apparently functional endoscopes after a period of clinical use and to characterize the prevalence and pattern of below-tolerance findings by scope type. Methods: We performed a quality improvement project to evaluate the tip angulation of newly issued endoscopes within nine months of clinical use. In phase 1, endoscopes were systematically assessed by 3 trained physicians using a reference chart. In phase 2, a company representative independently evaluated endoscopes using a calibrated instrument. Results: 32 new endoscopes (18 colonoscopes and 14 gastroscopes) were evaluated. All scopes were used for approximately 9 months. The mean procedure count for colonoscopes was 185.6 (± 12.5, range 162-201) and for gastroscopes was 150.6 (± 12.0, range 133-166). 5 out of 18 colonoscopes (27.8%) fell below manufacturer tolerance thresholds for maximal tip deflection in at least one direction. All 14 gastroscopes met manufacturer tolerance thresholds in all four directions. Conclusions: This cross-sectional study found that a notable proportion of new colonoscopes fell below manufacturer tolerance thresholds after approximately nine months of clinical use, despite being considered apparently functional. These findings highlight the need for periodic, objective assessment of tip angulation, even in endoscopes without apparent defects. Longitudinal studies are needed to establish deterioration trajectories and inform maintenance guidelines.

Endoscopy International Open
Rush University Medical Center (US), John H. Stroger, Jr. Hospital of Cook County (US)
Openalex Percentile: Top 6%
Medical Device Sterilization and Disinfection
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