MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SET

Model Number	MAJ-2027
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Gastrointestinal Problem (4491)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled, "feasibility and diagnostic yield of small-bowel capsule endoscopy in patients with surgically altered gastric anatomy: the saga study." background: little is known about small-bowel (sb) capsule endoscopy (ce) in patients with a history of gastric surgery.This study aims to evaluate the feasibility and diagnostic yield (dy) of orally ingested sb-ce in patients with surgically altered gastric anatomy.Methods: twenty-four european centers retrospectively identified patients who had sb-ce after total or subtotal gastrectomy.The primary outcome was the dy of sb-ce (intermediate p1 to highly p2 relevant findings).Secondary outcomes were gastric and sb transit times, completion, cleanliness, and adverse event rates.Results: studied were 248 procedures from 243 patients (mean age, 62 years) with a history of partial gastrectomy (billroth i, 13.1%; billroth ii, 34.6%), total gastrectomy (7.4%), whipple procedure (12.8%), sleeve gastrectomy (7.2%), or gastric bypass surgery (24.7%).Obscure gi bleeding was the most frequent indication (85.1%).Sb completion rate was 84.3%.One capsule retention in the sb was noted (adverse event rate,.4%).Median sb transit time was 286 minutes (interquartile range [235; 387]).Cleanliness was rated as adequate in 92.1% of procedures.After exclusion of abnormalities found at the upper anastomotic site, the dy was 43.6%, with inflammatory/ulcerated lesions observed more frequently (23.4%) than vascular lesions (21.0%).Conclusions: sb-ce seems to be feasible and safe in selected patients with a history of major gastric surgery and comes with a high dy.The spectrum of abnormal sb findings in these patients may be different from what is known from the literature in nonoperated patients.(gastrointest endosc 2021;94:589-97.) type of adverse events/number of patients: asymptomatic small bowel (sb) retention - 1 patient.There is no report of any olympus device malfunction in any procedure described in this study.
Additional Manufacturer Narrative
The suspect device was not returned to olympus.A dhr could not be checked because the serial number of the subject device was unknown.Investigation was conducted based on the complaint information.Based on the results of the investigation, it is likely the reported event is an accident, or a complication associated with a surgical procedure using the subject device.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.The literature article is attached to this report.

• Brand Name: ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SET
• Common Device Name: ENDOCAPSULE SMALL INTESTINAL CAPSULE ENDOSCOPE SET
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16850267
• Report Number: 3002808148-2023-04418
• Device Sequence Number: 6526625
• Product Code: NEZ
• UDI-Device Identifier: 04953170328268
• UDI-Public: 04953170328268
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K183053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2023

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-2027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2023
• Initial Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON-OLYMPUS - MIROCAM 1200; NON-OLYMPUS - MIROCAM 1600; NON-OLYMPUS - MIROCAM 2000; NON-OLYMPUS - OMOM; NON-OLYMPUS - PILLCAM COLON2; NON-OLYMPUS - PILLCAM SB2; NON-OLYMPUS - PILLCAM SB3; NON-OLYMPUS - PILLCAMSB1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown