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

Model Number GIF-HQ190

Device Problems Device Reprocessing Problem (1091); Device Contamination with Body Fluid (2317)

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

Event Date 03/17/2023

Event Type  malfunction  

Event Description

The customer reported to olympus the evis exera iii gastrointestinal videoscope failed a channel check swab three times used to check for the presence of carbohydrates, blood, or protein.The issue was found at reprocessing during a routine culture of the scope.The user did not report any patient/user harm or injury reported due to the event.

Manufacturer Narrative

At this time, no further information has been provided regarding the failed swab testing of this device.Should further details become available, this information will be provided.The device was returned to olympus for evaluation.During the device evaluation it was uncovered that the rfid and eto labels were peeling.It was also observed that there was a cut on switch 1 and a crack on the switch unit.It was observed that the angulation was low.It was also observed that the play of the control knob movement did not meet specifications.It was observed that the distal end plastic cover was scratched.It was also observed that the glue of the objective lens and the light guide lens were peeling.It was observed that the glue of the bending section cover was cracked.It was also observed that the insertion tube had a puncture or dent.It was observed that the light guide tube was scratched.Lastly, it was observed that the contact pin of the scope connector was scratched.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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 reported ¿failed channel check 3x after pre-cleaning¿ issue could not be reproduced and the root cause could not definitively be determined, however, it is probable that the issue was the result of insufficient reprocessing due to water leakage from the device forceps channel.In addition, the following non-reportable malfunction(s) were found during the device evaluation: instrument channel leak.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16757591
• MDR Text Key: 313656414
• Report Number: 9610595-2023-06262
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• 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