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

Model Number	SP8365
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in progress.A follow-up report will be submitted once 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.
Event or Problem Description
The user facility reported that during a patient procedure, the distal end of the snowden-pencer raptor grasper insert separated from the actuating rod.A procedure delay was reported.The procedure was completed successfully with a second raptor grasper.No report of injury.
Additional Manufacturer Narrative
The snowden-pencer, raptor grasper insert subject of the reported event was returned for evaluation.During evaluation of the returned device, it was determined that the jaw assembly had separated from the actuating rod.The root cause of the issue was determined to be mechanical overstress by user facility personnel.The instructions for use for the raptor grasper insert states, "avoid mechanical shock or overstressing the devices; this will cause damage." the device history record for the subject lot was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.A complaint review was conducted and determined the event to be isolated for the subject lot.In-service was offered on the proper use and operation of the raptor grasper insert; however, the user facility declined.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: SNOWDEN-PENCER RAPTOR GRASPER INSERT
• Manufacturer (Section D): STERIS CORPORATION; 5 sunnen dr; saint louis MO 63143
• Manufacturer (Section G): STERIS CORPORATION; 5 sunnen dr; saint louis MO 63143
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20918184
• Report Number: 1923569-2024-01016
• Device Sequence Number: 17425567
• Product Code: GCJ
• UDI-Device Identifier: 10885403171970
• UDI-Public: (01)10885403171970(10)B24
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 12/12/2024

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: SP8365
• Device Catalogue Number: SP8365
• Device Lot Number: (10)B24
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 02/13/2025
• 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