MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-2TH180

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

Patient Problem Unspecified Gastrointestinal Problem (4491)

Event Date 01/27/2023

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled, "long-term outcomes of transoral outlet reduction (tore) for dumping syndrome and weight regain after roux-en-y gastric bypass." background: both weight regain and dumping syndrome (ds) after roux-en-y gastric bypass (rygb) have been related to the dilation of gastro-jejunal anastomosis.The aim of this study is to assess the safety and long-term efficacy of endoscopic transoral outlet reduction (tore) for ds and/or weight regain after rybg.Materials and methods: a retrospective analysis was performed on a prospective database.Sigstad¿s score, early and late arts dumping score (ads) questionnaires, absolute weight loss (awl), percentage of total body weight loss (%tbwl), and percentage of excess weight loss (%ewl) were assessed at baseline and at 6, 12, and 24 months after tore.Results: eighty-seven patients (median age 46 years, 79% female) underwent tore.The median baseline bmi was 36.2 kg/m2.Out of 87 patients, 58 were classified as ¿dumpers¿ due to sigstad¿s score = 7.The resolution rate of ds (sigstad¿s score < 7) was 68.9%, 66.7%, and 57.2% at 6, 12, and 24 months after tore, respectively.A significant decrease in sigstad¿s score as well as in early and late ads questionnaires was observed (p < 0.001).The median sigstad¿s score dropped from 15 (11¿8.5) pre-operatively to 2 (0¿12) at 24 months.The %tbwl was 10.5%, 9.9%, and 8.1% at 6, 12, and 24 months, respectively.Further, ¿dumpers¿ with resolution of ds showed better weight loss results compared with those with persistent ds (p < 0.001).The only adverse event observed was a perigastric fluid collection successfully managed conservatively.Conclusion: tore is a minimally invasive treatment for ds and/or weight regain after rygb, with evidence of long-term efficacy.Types of adverse event(s)/ number of patients: perigastric collection/ n=1.There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

The literature referenced 2 olympus model number.Since the literature described a "double-channel therapeutic endoscope, gif 2ht180 or gif 2ht160", olympus selected model number "gif 2ht180" as a representative product with the same product name.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16483229
• MDR Text Key: 310681474
• Report Number: 9610595-2023-03734
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170339745
• UDI-Public: 04953170339745
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

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
• Device Operator: Health Professional
• Device Model Number: GIF-2TH180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/26/2023
• 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; Required Intervention