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

Model Number	FG-53SX-1
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the grasping forceps slider of the operation part moved once, but after that it stopped moving and the grip part did not open.The event occurred during reprocessing.There was no patient harm associated with the event.The device was evaluated, and it was found that proper reprocessing after use was not performed.This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was confirmed.In addition to proper reprocessing after use not being performed, additional findings were as follows: there was a kink located at approximately 20cm, 30cm, and 50 cm from the base of the insertion part; the cup could not be opened by operating the slider; and foreign matter was adhering to the linkage mechanism.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the lubricant was not applied properly, and foreign materials remained because the appropriate reprocessing was not performed according to the instruction manual.The event can be prevented by following the instructions for use (ifu) which state: "reprocess the instrument immediately after use, first by immersing it in a neutral, low-foaming, medical grade detergent solution, then following the cleaning and sterilization procedures given in this chapter.Failure to reprocess the instrument immediately after use, or using other than a medical-grade detergent may cause corrosion at the metal parts like the grasping jaws.This could impair the operation of the instrument or cause a part of it to break and/or fall off inside the patient.Lubrication 1.Immerse the insertion portion in the basin containing lubricant for 2 to 3 seconds.2.Remove the instrument from the lubricant.3.Operate the slider to open and close the grasping jaws two or three times.4.Wipe the exterior of the instrument with a clean, dry lint-free cloth and allow the instrument to air dry." 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: 17743894
• Report Number: 9614641-2023-01317
• Device Sequence Number: 5461428
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023

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: K2X11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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