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

Model Number	FG-44NR-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During device evaluation at olympus, it was found the handle of the forceps was discolored and there was a lot of dirt accumulated at the jaws and joint.The joint of the jaws was damaged and broken.Corrosion and holes were detected from the tip and joint of the jaws.The tooth of the jaw was damaged and missing.The device was cleaned using 3m multi enzyme detergent for endoscopes.A neutral, low-foaming, medical grade detergent was used for cleaning, disinfection and sterilization.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Although a definitive root cause of the foreign material could not be determined, likely factors causing the issue could have been the following: 1 - foreign materials or cleaning solution had left on the arm of the grasping jaws due to insufficient cleaning of the device.2 - residues on the arm of the grasping jaws corroded and decreased its strength.3 - a force was applied to the linkage mechanism while handling the device.As a result, the linkage mechanism part where decreased its strength was broken and fell off.The customer may be able to reduce and prevent occurrence of the event by handling device in accordance with the instructions for use (ifu).- 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.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer reported the distal end of the rotatable grasping forceps was faulty.The issue was found when preparing for a therapeutic procedure to remove a foreign body.This was the second time the device was going to be used.The distal end broke outside of the patient's body and a similar device was used to complete the procedure.The procedure was not delayed over 15 minutes.There was no reported patient harm or impact due to this event.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19060136
• Report Number: 9614641-2024-00866
• Device Sequence Number: 17607252
• Product Code: EOQ
• UDI-Device Identifier: 04953170032196
• UDI-Public: 04953170032196
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2024

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: 99K(GTQML)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2020
• Initial Report FDA Received Date: 04/08/2024
• 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