MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE GRASPING FORCEPS FG-804L; DISPOSABLE GRASPING FORCEPS

Model Number	FG-804L
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that the single use grasping forceps fg-804l did not open while it was grasping the gastrostomy-jejunostomy (gj) tube in the middle of a therapeutic procedure to replace a gj tube.Other than cutting the forceps, pulling it out, and checking for any foreign bodies, no other intervention was done outside the planned case.The procedure was prolonged by 30 minutes, twice as long as anticipated, with the patient under anesthesia.However, there were no other complications noted.

• Brand Name: SINGLE USE GRASPING FORCEPS FG-804L
• Common Device Name: DISPOSABLE GRASPING FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 18034 -061; JA 18034-0610
• MDR Report Key: 16827532
• Report Number: 2429304-2023-00083
• Device Sequence Number: 16621105
• Product Code: EOQ
• UDI-Device Identifier: 04953170435874
• UDI-Public: 04953170435874
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/27/2023
• Report Date (Section F): 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG-804L
• Device Lot Number: 1XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 YR
• Patient Sex: Unknown