MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE GRASPING FORCEPS FG-253SX; DISPOSABLE GRASPING FORCEPS

Model Number	FG-253SX
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a packaging issue with the subject device that resulted in an unsterile product.The issue was identified during set up / inspection for use (during set up in room / before patient in room).There were no reports of patient involvement.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
The device was returned to olympus for inspection without the original package with lot# 41k 24 on the physical device.The reported complaint was not confirmed.The physical device was inspected with no issues.The jaw/clip from the distal end opens and closes properly when the slider is manipulated.There were no external damages noted with the device itself.The reported complaint was not confirmed due to the original package was not received to determine the user's complaint.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• Brand Name: SINGLE USE GRASPING FORCEPS FG-253SX
• Common Device Name: DISPOSABLE GRASPING FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22176835
• Report Number: 9614641-2025-00942
• Device Sequence Number: 7789202
• Product Code: PTS
• UDI-Device Identifier: 04953170412059
• UDI-Public: 04953170412059
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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
• Operator of Device: Health Professional
• Device Model Number: FG-253SX
• Device Lot Number: 41K 24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown