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

Model Number GIF-Q150

Device Problems Partial Blockage (1065); Particulates (1451)

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

Event Date 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an olympus repair facility, and an evaluation of the device was performed.During the evaluation, foreign material was discovered in the nozzle of the device, and the a-rubber piece was dirty.The customer's originally reported issues of low angulation and free play in the scope were also confirmed.The following additional findings were noted: 1.C-cover has a dent.2.Connecting tube has discoloration.3.S-cover has a scratch.4.Control unit has a scratch.5.Universal cord has discoloration.6.S-connector has a scratch.7.Due to deformation of bending tube, bending angle in up&right direction does not meet the standard value.8.Due to wear of angle wire, bending angle in down direction does not meet the standard value.9.Knobs play.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

An olympus representative reported on behalf of the customer that, during reprocessing, it was noted that there was low angulation and play in their gastrointestinal videoscope.Upon inspection and testing of the returned unit, foreign material was found in the nozzle of the device.The foreign material was noted to be ocher in color, and it could not be identified.Additionally, it was discovered that the a-rubber component was dirty.There was no patient involvement associated with this event, as the issues were identified at bench.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to insufficient or inadequate reprocessing.The event can be detected and prevented by following the instructions for use (ifu) sections which state: detection method is described in operation manual chapter 3 preparation and inspection.Preventive measure is described in reprocessing manual 3.3 precleaning, 3.5 manual cleaning.Olympus will continue to monitor field performance for this device.

• Brand Name: 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: 16352503
• MDR Text Key: 309512796
• Report Number: 9610595-2023-02234
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170307485
• UDI-Public: 04953170307485
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-Q150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 08/24/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2022
• 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