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

Model Number	SP8364
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	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure the tip of the crocodile grasper broke off and fell into the patient.No report of injury.
Additional Manufacturer Narrative
Our investigation into the reported event is in process.A follow-up report will be submitted when additional information becomes available."udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.".
Additional Manufacturer Narrative
The device subject of the event was discarded by the user facility and not available for evaluation.Without the return and evaluation of the device, the cause of the reported event cannot be determined.The user facility was unable to provide the lot number for the crocodile grasper, therefore, a review of the device history record could not be performed.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: CROCODILE 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 rd; mentor, OH 44060 ; 4402597401
• MDR Report Key: 22965612
• Report Number: 1923569-2025-00012
• Device Sequence Number: 9137331
• Product Code: GCJ
• UDI-Device Identifier: 10885403171956
• UDI-Public: (01)10885403171956
• 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,Followup
• Report Date (Section B): 09/04/2025

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: SP8364
• Device Catalogue Number: SP8364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/22/2025
• 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
• Patient Sex: Unknown