MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, TOOTHED, 5 FR. X 640 MM, FLEXIBLE

Model Number	A2421
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation and follow up with the user facility is currently being performed.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the use of the grasping forceps, during removal of the stent placed a week earlier (ureteroscopy) took the user several attempts to grasp the stent and ultimately used an old olympus grasper to use to remove it.Though the procedure was extended for an unspecified amount of time during the attempts and to retrieve the other grasper, it was completed without reports of user/patient adverse events.The procedure was done under local anesthesia which poses patient to low risk for harm/adverse effects.There is no evidence that a life-threatening event occurred, that the patient developed permanent damage or impairment, and that additional medical/surgical intervention was done to prevent permanent damage or impairment.
Additional Manufacturer Narrative
The event date was inadvertently added to the initial report, it is unknown.This report is being supplemented to provide additional information provided by the territory manager and based on the legal manufacturer's final investigation.Please also see updates to e2, e3, and h6.The territory manager reported on behalf of the customer multiple physicians stated they had to switch to different graspers to finish their case.Three additional complaints were opened with the patient identifiers (b)(6)to address the reported events.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 and because the subject device was not returned for evaluation, the reported event could not be confirmed and a root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: GRASPING FORCEPS, TOOTHED, 5 FR. X 640 MM, FLEXIBLE
• Common Device Name: FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17514561
• Report Number: 9610773-2023-02206
• Device Sequence Number: 8193461
• Product Code: FGB
• UDI-Device Identifier: 04042761003308
• UDI-Public: 04042761003308
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K852888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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: A2421
• Device Lot Number: 23201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• 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