MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; GRASPER

Model Number	LAT-0536-DG20
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in progress; a follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported while using their dorsey fenestrated grasper during patient procedures that a screw fell into the surgical field.No report of injury or procedure delay.
Additional Manufacturer Narrative
The dorsey fenestrated grasper devices subject of the reported events were returned to the supplier for evaluation.The evaluation determined that both devices showed evidence of improper repair activities by a third-party servicer which may have contributed to the screw detaching during the reported events.Further, there was evidence of attempts to repair loose rivets using laser welding on the devices based on observed grinding marks, torn holes, and broken pins.The dorsey fenestrated grasper device instructions for use states, "return devices to an authorized repair service center, such as steris ims, for repair or replacement." the instructions for use additionally instructs the user facility to inspect the instrument for loose components prior to use, "all devices must be examined for full functionality prior to and after use.Inspect for hindered movement of hinges, loose components, and chipped or worn parts." steris offered in-service training on the proper use and operation of the dorsey fenestrated grasper device, specifically using an authorized repair service center and inspecting for loose components before use; however, the user facility declined.The device history records for the dorsey fenestrated grasper devices subject of the event were reviewed and confirmed the devices were manufactured to specifications; no abnormalities were noted.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported while using their dorsey fenestrated grasper device during two patient procedures that a screw fell into the surgical field.No report of injury or procedure delay and both procedures were successfully completed.The patients received medical treatment (x-rays) following the reported event, which confirmed a screw did not fall into either patient.

• Brand Name: V. MUELLER
• Common Device Name: GRASPER
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor 44060
• Manufacturer (Section G): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4402597401
• MDR Report Key: 22541089
• Report Number: 1527821-2025-00012
• Device Sequence Number: 6975161
• Product Code: GEI
• UDI-Device Identifier: 10885403431272
• UDI-Public: (01)10885403431272(10)L19XBM
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: LAT-0536-DG20
• Device Catalogue Number: LAT0536DG20
• Device Lot Number: (10)L19XBM, (10)J23XBM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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