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

Model Number GIF-H180J

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

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

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, no air water flow detected due to clogged nozzle with foreign object, after clogging was removed, air water flow was normal, distal end cover insulation value equal to zero, distal end cover dented, angle rubber glue cracked, objective lens chipped, objective lens glue had hole, light guide lens glue cracked, angulation low, control knob paly, right/left/up/down knob heavy when engage and label illegible peeling.The faulty parts will be replaced, and the device will be returned to the user facility.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 reported to olympus that during reprocessing of the evis exera ii gastrointestinal videoscope, the scope had irrigation issue.Upon inspection and testing of the returned device, foreign material was found clogged in the scope air/water nozzle due to insufficient cleaning.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no patient involvement reported with this event.

Manufacturer Narrative

Updated: h6, h10.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 observed foreign matter clogging the nozzle could not be identified and a definitive root cause of the issue could not be determined, as there was no device deformation the could have contributed to the retention of foreign material and no additional event or device reprocessing information was reported.The event can be detected/prevented by following the instructions for use sections below: evis exera ii gif/cf/pcf type 180 series operation manual chapter 3 preparation and inspection.Evis exera ii gif/cf/pcf type 180 series reprocessing manual chapter 5 reprocessing the endoscope (and related reprocessing accessories) describes preventive measures).Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 16850273
• MDR Text Key: 314560488
• Report Number: 9610595-2023-06954
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170275456
• UDI-Public: 04953170275456
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H180J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2016
• 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