MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H170

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 03/19/2021

Event Type  Injury  

Manufacturer Narrative

This event has been reported by the importer on mdr# 2951238 ¿ 2022- 00423.Model number: the literature reports gif-h160, gif-h170 chosen as a representative product.The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported in the literature article titled ¿usefulness of fluoroscopy for endoscopic balloon dilation of crohn's disease-related strictures¿; a patient experienced a perforation during a procedure using one of four olympus scopes.Case with patient identifier (b)(6) reports gif-q160.Case with patient identifier (b)(6) reports pcf-h180.Case with patient identifier (b)(6) reports gif-h160.Case with patient identifier (b)(6) reports pcf-q160.Background: fluoroscopy is often used for endoscopic balloon dilation (ebd) of crohn's disease (cd)-related strictures.However, its benefit remains unclear.Aims: to compare ebd with (ebdf) and without (ebdnf) fluoroscopic guidance in cd patients with strictures.Methods: single-center, nested, case-control retrospective study of ebd for cd-related strictures.Technical and clinical success and safety outcomes were compared between ebdf and ebdnf.Results: a total of 122 strictures in 114 cd patients who underwent ebd from 2010 to 2018 at a single institution were reviewed (44 patients ebdf vs.70 ebdnf).Esophagogastroduodenoscopy was the approach in 8 strictures, colonoscopy in 86, and deep enteroscopy in 28.There were no significant differences in the rates of technical and clinical success, need for repeat dilation and surgery between the two groups, although the mean maximal endoscopic balloon diameter was larger in the ebdnf group (17.1 ± 1.9 vs.14.1 ± 2.5; p < 0.001).There was one perforation in ebdf and no serious complications in ebdnf.In multivariate analysis, balloon size < 15 mm (odds ratio [or] 6.388; 95% ci 1.96-20.79; p = 0.002) and multiple strictures (or 3.897; 95% ci 1.09-14.01; p = 0.037) were associated with repeat ebd, and age < 50 years (or 7.178; 95% ci 1.38-37.44; p = 0.019) and small bowel (vs.Colon) location (or 7.525; 95% ci 1.51-37.47; p = 0.014) were associated with the need for surgery after ebd.Conclusions: ebd for cd-related strictures can be performed safely and effectively without fluoroscopic guidance.Balloon size, patient age, stricture location, and multiplicity are associated with clinical success and avoidance of surgery.There was only one serious adverse event, a perforation which occurred in one patient who underwent dilation under fluoroscopy.There were no patient¿s who developed severe bleeding or required hospitalization for pain after balloon dilation in either group.There is no report of any olympus device malfunction reported in any procedure described in this literature.

Manufacturer Narrative

Correction: b5.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and a correction.New information was added to the following fields: d4, d8, h6, h10.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

Event Description

Case with patient identifier (b)(6) reports pcf-h180al.Case with patient identifier (b)(6) reports gif-h170.Case with patient identifier (b)(6) reports pcf-h170l.

• Brand Name: GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14641731
• MDR Text Key: 293619689
• Report Number: 8010047-2022-09706
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170334115
• UDI-Public: 04953170334115
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-H170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 06/16/2022
• Supplement Dates FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other