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

Model Number GIF-HQ190

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.Three attempts were performed to obtain additional information, but no response was received from the customer.Based on the results of the investigation, a definitive root cause cannot be identified.This issue is addressed in the instructions for use (ifu): the user can prevent the suggested event by reprocessing the device in accordance with the reprocessing manual 'chapter 5 reprocessing the endoscope'.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor the field performance of this device.This report is related to mfr 08210 (1/2).

Event Description

It was reported that the gastrointestinal videoscope was not sterile during a bariatric procedure.There were no reports of patient harm.

• Brand Name: EVIS EXERA III 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19140257
• MDR Text Key: 341464356
• Report Number: 9610595-2024-08216
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2023
• 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
• Treatment: TJF-Q190V DUODENOVIDEOSCOPE