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

Model Number	FB-56D-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that, during a biopsy of the ureter (flexible ureteroscopy), the forceps could not be opened when the biopsy was retrieved.The handle worked but the cup on the subject device remained closed.This caused a five minute delay in the procedure.There was no effect on the patient due to the event.The subject device was sent to olympus for evaluation.During inspection and testing, the arms of the caps (a part of the linkage mechanism at the distal end) was broken off.This report is being submitted for the malfunction found during evaluation (broken arms).
Additional Manufacturer Narrative
During inspection and testing, the arms of the caps (a part of the linkage mechanism at the distal end) was broken off.The broken arms had brown foreign material around the broken area and the arms were missing.The broken surface indicated a brittle fracture due to corrosion.A review of the device history record found no deviations that could have caused or contributed to the broken arms.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the cup did not open because the linkage mechanism was broken.The linkage mechanism is likely broken because foreign materials or cleaning solution were left on the arm of the cups due to insufficient cleaning of the device.The residue on the arm of the cups corroded and decreased its strength which caused it to break when force was applied to the linkage mechanism while handling the device.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warning, which may help to prevent the issue: "before use, confirm that the distal tip of the forceps is not corroded, dented or discolored, and that the cups can be opened and closed smoothly.Using forceps that are damaged or not working properly may result in one or more of its components falling off inside the patient.If a component falls off of the distal end, or if operation of the cups suddenly becomes more difficult, immediately stop the procedure.Carefully withdraw the forceps together with the endoscope to avoid causing injury within the body cavity.Retrieve any parts that have fallen off inside the patient using another grasping forceps." "reprocess the instrument immediately after use by immersing it in a neutral, low-foaming, medical-grade detergent solution, then following the cleaning and sterilization procedures in this chapter.Failure to reprocess the instrument immediately after use, or using another type of detergent may cause corrosion at the instrument¿s distal end.This could cause components to fall off during use and may interfere with operation of the cups." olympus will continue to monitor field performance for this device.

• Brand Name: BIOPSY FORCEPS
• Common Device Name: BIOPSY 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: 15955244
• Report Number: 9614641-2022-00745
• Device Sequence Number: 15093416
• Product Code: GCJ
• UDI-Device Identifier: 14953170048828
• UDI-Public: 04953170048821
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K013617
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/09/2022

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: FB-56D-1
• Device Lot Number: K9628-2884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2019
• 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