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

Model Number GIF-HQ190

Device Problem Device Damaged by Another Device (2915)

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

Event Date 01/31/2024

Event Type  Injury  

Event Description

It was reported that during a stomach biopsy procedure, a non-olympus forceps was caught within the gastrointestinal videoscope.The forceps joint came undone and the physician was unable to close the instrument.It was decided to pull hard on the scope and the forceps finally broke apart and the forceps were pulled through the scope's working channel.This was believed to have caused damage to the scope but it was stated that the issue was the dysfunctional forceps, not the scope.The forceps pieces were retrieved from the patient with a net, which created a 40 minute procedural delay while the patient was under anesthesia.Diagnostic imaging was utilized during the procedure as well as post operatively to confirm no retained forceps pieces were present within the patient.The procedure was completed but the scope failed the leak test immediately after the procedure and was taken out of service.The condition of the patient was not impacted by the failure.

• 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
• MDR Report Key: 18955666
• MDR Text Key: 338308693
• Report Number: 2429304-2024-00206
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/01/2024,03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/19/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BOSTON SCIENTIFIC FORCEPS
• Patient Outcome(s): Other