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

Model Number GIF-Q150

Device Problems Contamination /Decontamination Problem (2895); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

Section e1: address - line 1: (b)(6).The device was returned as part of the asset return process.It was noted that the amount of water contact and water removal ability did not meet standard value due to clogging of the nozzle.It was also noted that the objective lens and light guide lens had a scratch.The plastic distal end cover had a dent and the adhesive on the bending section rubber was detached.The bending section rubber had discoloration and the bending angle in the up/down/left/right directions did not meet standard value due to wear of the angle wire.The scope cover had a scratch and discoloration.The grip had a scratch and the scope cylinder was shaved.The forceps channel port was shaved and the universal cord had a scratch.The water supply connector was loose and the light guide cover glass and scope cover unit had a scratch.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer returned a loaner gastrointestinal videoscope.Inspection and testing of the returned device found that the nozzle had foreign objects.There were no reports harm associated with the event.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's 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 foreign material was insufficient cleaning.Identification of the material could not be determined.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: 17132436
• MDR Text Key: 317210840
• Report Number: 9610595-2023-08882
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170229435
• UDI-Public: 04953170229435
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2023

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: 05/17/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2010
• 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