MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H190

Device Problems Partial Blockage (1065); Failure to Clean Adequately (4048)

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

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus and the customer¿s allegation was confirmed.During the inspection of the returned device, there was no passage in the instrument channel.There were deep dents and scratches on the distal end of the plastic cover.There was a dent on the rubber of the bending section, a crack on the glue on the rubber of the bending section cover and a cut on the rubber of the bending section cover.There was a buckle on the insertion tube and the switch button number one (1) was cut and misaligned.There was low angulation and the control knobs were experiencing play.The glue on the objective and light guide lenses were worn.The nozzle was not drying in ten (10) minutes, the production label was peeling and the water was mixed with air.The investigation is ongoing and follow up with the user facility is currently being performed.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 an unknown diagnostic procedure, the doctor observed that there might have been something obstructing the forceps channel on the evis exera iii gastrointestinal videoscope.There is a possibility the obstruction might be caused by insufficient cleaning.There were no reports of patient harm associated with this event.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation, device history record (dhr) review and additional information provided by the customer.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The exact cause of the obstructed channel could not be determined.However, it is likely that user handling or inappropriate reprocessing may have caused foreign material (including an endo therapy accessory) being present in the device causing an obstruction or a kink in the channel causing the obstruction.Users can detect the suggested event properly by handling the device in accordance with the operation manual¿s instructions for use (ifu): inspection of the endoscopic system_inspection of the instrument channel: ¿insert the endotherapy accessory through the biopsy valve.Confirm that the endotherapy accessory extends smoothly from the distal end.Also make sure that no foreign objects come out of the distal end.Confirm that the endotherapy accessory can be withdrawn smoothly from the biopsy valve.¿ users can decrease/prevent the suggested event by handling the device in accordance with the following ifu (reprocessing manual).Manually cleaning the endoscope and accessories_brush the channels ¿brush from the suction cylinder to the distal end of the insertion section (this brushes the instrument channel in the insertion section and the suction channel in the control section)¿.Olympus will continue to monitor the field performance of this device.

Event Description

Additional information was obtained from the customer.The failure occurred towards the end of the procedure.No other devices were replaced or were involved in this event.The procedure was completed using the same device and there was no delay.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13390739
• MDR Text Key: 295718732
• Report Number: 8010047-2022-02164
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

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-H190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 03/07/2022
• Supplement Dates FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2019
• 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