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 Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a therapeutic "cycstolitho taxy" procedure under general sedation, two screws dislodged from the rigid windowed grasping forceps and the device came apart when it was opened to grasp a stone.One of the screws fell into the patient¿s bladder from the distal end of the device that activates the opening and closing of the device.The dislodged screw was successfully retrieved using an evacuator from an unknown manufacturer.No additional diagnostic imaging was performed to locate or confirm removal of the screw.The even caused a delay of approximately 25¿30 minutes.The procedure was subsequently completed using an olympus backup device, and the patient reported to be doing fine.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.The most probable cause of the discovered damage is cause not established, which is the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event due to no device problem found.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: 23644236
• Report Number: 3011050570-2025-01370
• Device Sequence Number: 9646465
• Product Code: KOA
• UDI-Device Identifier: 00821925008342
• UDI-Public: 00821925008342
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EVACUATOR, UNKNOWN MANUFACTURER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown