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

Model Number	FG-44NR-1
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the grasping forceps had a brown charred substance observed inside the sterilized pack.The issue occurred during reprocessing.There were no reports of patient harm.
Additional Manufacturer Narrative
E1/establishment name: (b)(6) hospital.To date, the device has not been returned.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The legal manufacture reviewed the customer provided the cleaning disinfection and sterilization processes where deviations from instructions for use were identified.Based on the results of the investigation, it is likely the following led to the malfunction: -the sterilization time was longer than recommended, which may have contributed to the addition of a lot of heat from the outside.-the actual sterilization time was 80 minutes, which was not recommended, compared to the recommended sterilization time of 5 minutes.-as for the scorching of the packs, we do not believe it is due to the product, as we believe that more heat than usual was applied from the outside.-as for the stains on the packs, it is possible that there was moisture in the packs during sterilization, which seeped into the packs and left marks.-a definitive root cause cannot be determined.The event can be detected and prevented by following the instructions for use: -place the sealed package containing the instrument in the autoclave and sterilize in accordance with the conditions listed below.For details on operation of the autoclave, refer to the instruction manual for the autoclave or other manufacturer instructions.Olympus will continue to monitor field performance for this device.

• Brand Name: ROTATABLE GRASPING FORCEPS
• Common Device Name: ROTATABLE 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: 18866151
• Report Number: 9614641-2024-00622
• Device Sequence Number: 8148392
• Product Code: EOQ
• UDI-Device Identifier: 04953170032196
• UDI-Public: 04953170032196
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962533
• 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): 04/25/2024

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-44NR-1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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