MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12° AND 30° TELESCOPE; RIGID ENDOSCOPIC STONE-RETRIEVAL FORCEPS, REUSABLE

Model Number	A20710A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the rigid endoscopic stone-retrieval forceps jaw's distal end broke and had loose broken parts.The event was found during reprocessing.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information and the legal manufacturer's final investigation results.The device was returned to olympus.This evaluation was evaluated, and the result was deemed as not plausible.The attached photo in the evaluation tab show no recognizable damage in the mouth area.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, the overload safety of the item was triggered as a result of a massive overload in order to prevent breakage or similar damage in the jaw area.Olympus will continue to monitor field performance for this device.

• Brand Name: GRASPING FORCEPS, OPTICAL, FOR LITHOTRIPSY, FOR 12° AND 30° TELESCOPE
• Common Device Name: RIGID ENDOSCOPIC STONE-RETRIEVAL FORCEPS, REUSABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg/de/germany
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19051976
• Report Number: 9610773-2024-00965
• Device Sequence Number: 6992376
• Product Code: GCP
• UDI-Device Identifier: 04042761019989
• UDI-Public: 04042761019989
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: A20710A
• Device Lot Number: 22Z05-0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2023
• 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