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  

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.

• 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
• MDR Report Key: 14641703
• MDR Text Key: 293614893
• Report Number: 2951238-2022-00423
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2022,06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• 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?: Yes
• Distributor Facility Aware Date: 05/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other