MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. GRASPING FORCEPS

Model Number	FG-53SX-1
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the grasping forceps had burnt deposits.The issue occurred during receipt inspection for a therapeutic procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
The component code has been corrected from jaw to cover.This report is being supplemented to provide additional information based on the device evaluation and the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The subject device was returned and evaluated where upon inspecting the laser-welded area at the distal end of the coil sheath, discoloration was observed due to the heat from the laser welding process.The area was welded all around and not adhered with sputter according to specifications.No sputter (particle produced during welding) was adhered to the area, and there were no visible abnormalities in its appearance.Upon comparing the subject product with the aomori olympus inventory, the discoloration at the laser-welded area was found to be nearly identical in both.Based on the results of the investigation, it is determined that the product did not have any abnormalities.The black portion of the coil sheath is the trace of laser welding.This does not affect the functionality or safety of the product.Since the device malfunction was not confirmed during evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: GRASPING FORCEPS
• Common Device Name: 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19173636
• Report Number: 9614641-2024-00973
• Device Sequence Number: 7817768
• Product Code: PTS
• UDI-Device Identifier: 04953170049040
• UDI-Public: 04953170049040
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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-53SX-1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown