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

Model Number GIF-1200N

Device Problems Defective Component (2292); Failure to Clean Adequately (4048)

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

Event Date 10/04/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation of ¿internal defects of channel¿ was not confirmed.The device evaluation found the nozzle had foreign objects due to insufficient cleaning.Additionally, due to wear of the angle wire, bending angle in up direction did not meet the standard value.Due to wear of the angle wire, the play of up/down knob was out of the standard value.And the adhesive on the bending section cover had a chip.The customer later confirmed that they cleaned, disinfected, and sterilized the product before returning it for evaluation, and that they were not sure what the foreign material adhered to the scope¿s nozzle was.Additionally, it was confirmed there was no delay in the start of pre-cleaning, the customer did not confirm if they¿ve flushed the nozzle with water and air, the customer did not confirm if there were any abnormalities in the accessories used for reprocessing.They did not confirm whether they¿ve presoaked the endoscope in detergent solution, they wiped the nozzle with clean lint-free cloths/brushes/sponges, and they flushed the air/water nozzle with detergent solution.There were no other concerns regarding the reprocessing.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, the foreign material was unable to be specified and a definitive root cause could not be established.A device history review (dhr) revealed of the subject device was reviewed and it was confirmed that the device was shipped in compliance with specifications.This issue is addressed in the instructions for use (ifu): the subject event can be detected and prevented by implementation in accordance with the ifu below.Instructions, operation manual for gif-1200n chapter 3 ¿preparation and inspection¿ describes how to detect the subject event.Instructions, reprocessing manual for gif-1200n chapter 5 ¿reprocessing of the endoscope (and related reprocessing accessories)¿ describes how to prevent the subject event.Olympus will continue to monitor the field performance of this device.

Event Description

The customer reported internal defects of channel on the gastrointestinal videoscope.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was identified: foreign object in nozzle.There were no reports of patient or user harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18069712
• MDR Text Key: 327375708
• Report Number: 9610595-2023-16471
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/03/2023

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-1200N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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