MAUDE Adverse Event Report: GYRUS ACMI, INC. RIGID WINDOWED GRASPING FORCEPS, 3MM, 37CM; SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Model Number	RWG-337R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if this device will be returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The customer reported to olympus that during percutaneous nephrolithotomy, this grasping forceps broke.The pin that holds the jaws in place was missing and presumed that it is inside the patient.Attempts to obtain additional information was made, however, unsuccessful.There were no reports of patient or user harm associated with this event.
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, since there was no device return, the complaint could not be confirmed.Although attempts were made to obtain further event details, there was no additional information provided by the customer.Therefore, the root cause of the reported failure could not be identified.This supplemental report includes information added to d8 and d9.Olympus will continue to monitor field performance for this device.

• Brand Name: RIGID WINDOWED GRASPING FORCEPS, 3MM, 37CM
• Common Device Name: SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17051299
• Report Number: 3011050570-2023-00053
• Device Sequence Number: 15220631
• Product Code: KOA
• UDI-Device Identifier: 00821925008342
• UDI-Public: 00821925008342
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT-KOA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RWG-337R
• Device Lot Number: JF
• Was Device Available for Evaluation?: No
• 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: 05/03/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown