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

Model Number	SP8385
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The snowden-pencer wavy grasper subject of the reported event was not returned for evaluation; however, user facility personnel provided a photo of the device.The photo of the device was evaluated, and it was observed that the pin joining the jaw to the rod-link was damaged which is indicative of excess force by user facility personnel.The snowden-pencer wavy grasper instructions for use states, "avoid mechanical shock or overstressing the device.Ensure the jaws are fully closed before insertion or removal through cannulas.Pulling the instrument straight out to avoid catching or dislodging cannula components.Avoiding lateral pressure during removal, which can damage the working tip, shaft, or insulation." the device history record was reviewed and confirmed the lot was manufactured to specifications; no abnormalities were noted.A 2-year complaint review indicates this to be an isolated event.A steris account manager conducted in-service training with user facility personnel on the proper use and operation of the snowden-pencer wavy grasper.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure the tip of the snowden-pencer wavy grasper fell into the patient.The tip was retrieved, and the procedure was completed successfully.The patient received an x-ray and confirmed no instrument pieces were present.No report of injury.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: WAVY GRASPER
• Manufacturer (Section D): STERIS CORPORATION; 5 sunnen drive; maplewood MO 63143
• Manufacturer (Section G): STERIS CORPORATION; 5 sunnen drive; maplewood MO 63143
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24840455
• Report Number: 1923569-2026-00003
• Device Sequence Number: 5952513
• Product Code: GCJ
• UDI-Device Identifier: 10885403224928
• UDI-Public: (01)10885403224928(10)E24
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K991928
• 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
• Report Date (Section B): 04/10/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: SP8385
• Device Catalogue Number: SP8385
• Device Lot Number: (10)E24
• 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: 03/13/2026
• Initial Report FDA Received Date: 04/10/2026
• 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