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

Model Number GIF-HQ190

Device Problems Device Reprocessing Problem (1091); Mechanical Problem (1384)

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

Event Date 04/14/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device inspection , and as requested by the customer, service repair performed forceps passage check and found tear marks on walls of the channel.In addition, the distal end plastic cover found with dents and scratches.The a-rubber (bending section) c-cover was noted with crack including the (i/t) insertion tube.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported during reprocessing , metal debris was expelled from the device.According to the customer, the unit passed leak test however, would like an inspection of the device to ensure no internal damage exists.There was no patient harm or injury reported.No user injury reported.

Manufacturer Narrative

Correction to e3, the reporters title was biomedical engineer.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, a definitive root cause could not be determined.However, that it is likely that a part of an accessory was broken and exited from the biopsy channel due to inappropriate accessory handling by the user.The following is included in the instructions for use (ifu) and may have helped prevent the event: "inspection of the instrument channel" "if insertion or withdrawal of endotherapy accessories is difficult, straighten the bending section as much as possible without losing the endoscopic image.Inserting or withdrawing endotherapy accessories with excessive force may damage the instrument channel or endotherapy accessories and could cause some parts to fall off and/or cause patient injury." "if the distal end of an endotherapy accessory is not visible in the endoscopic image, do not open the distal end or extend the needle of the endotherapy accessory.This could cause patient injury, bleeding, perforation, and/or equipment damage." "for more information on combining the endoscope with particular endotherapy accessories, refer to combination equipment and the instruction manuals for the accessories.Also, refer to their respective instruction manuals for operating the accessories." 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): 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: 14366388
• MDR Text Key: 291512523
• Report Number: 8010047-2022-08093
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

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-HQ190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: 06/14/2022
• Supplement Dates FDA Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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