MAUDE Adverse Event Report: STERIS CORPORATION SNOWDEN-PENCER; GRASPER MODULAR

Model Number	88-8335
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event is pending return for evaluation.Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure their snowden-pencer slidelock atraumatic grasper modular "snapped at the joint".The procedure was completed successfully with another device.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was returned to the supplier for evaluation.The cause of the reported event is attributed to excess force applied by user facility personnel while using the handle.The snowden-pencer slidelock ratchet handle ifu states, "the use of excessive force may result in medical devices which malfunction.Regardless of age, any devices requiring service should be returned to the dealer." a steris account manager provided in-service training on the proper use and operation of the handle.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: GRASPER MODULAR
• 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 ; 4403927453
• MDR Report Key: 21885670
• Report Number: 1527821-2025-00005
• Device Sequence Number: 15501313
• Product Code: HFI
• UDI-Device Identifier: 10885403219924
• UDI-Public: (01)10885403219924(10)A22VEO
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

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: 88-8335
• Device Catalogue Number: 888335
• Device Lot Number: (10)A22VEO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/17/2025
• 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