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

Model Number	FG-44NR-1
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and the evaluation found problems caused by improper reprocessing.The product lot number was unknown.The investigation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the rotatable grasping forceps had foreign material in the sterile pack.This issue occurred during reprocessing.There were no reports of patient harm or injury.
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.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: after placing the sterilized pack containing the grasping forceps into the autoclave device, autoclave it within the following conditions.Other conditions during actual sterilization should be carried out in accordance with various cleaning and sterilization guidelines and recommendations from the sterilizer manufacturer.Follow facility-specific guidelines for procedures when performing autoclave sterilization.In addition, when operating the autoclave device, please follow the autoclave device's ``insert document or electronic package insert'' or ``instruction manual'' or the manufacturer's 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: 18821965
• Report Number: 9614641-2024-00545
• Device Sequence Number: 11893517
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• 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: 04/18/2024
• Initial Report FDA Received Date: 03/01/2024
• 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