MAUDE Adverse Event Report: STERIS CORPORATION SNOWDEN-PENCER; FLAT NOSE DISSECTOR INSERT

Model Number	SP8341
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	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported the tip to their flat nose dissector insert detached during a patient procedure.Employee received medical treatment (x-rays) following the reported event.No report of injury.
Additional Manufacturer Narrative
The flat nose dissector insert subject of the reported event is being returned for evaluation.Investigation of the reported event is in progress; 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.
Event or Problem Description
The user facility reported the tip to their flat nose dissector insert detached during a patient procedure.The procedure was successfully completed without delay utilizing an additional device.The employee received medical treatment (x-rays) following the reported event.No report of injury.
Additional Manufacturer Narrative
The flat nose dissector insert subject of the reported event was returned to steris for evaluation.The evaluation found evidence of overstress damage indicative of excessive force during use of the device.The flat nose dissector insert instructions for use states, "avoid mechanical shock or overstressing the devices; this will cause damage." a steris account manager offered in-service training on the proper use and operation of the flat nose dissector insert; however, the user facility declined.The device history record for this lot was reviewed and confirmed the device was manufactured to specifications; no abnormalities.No additional issues have been reported.
Additional Manufacturer Narrative
Contrary to the previous report, it was the patient that received an x-ray, not the employee.Additionally, the results of the x-ray confirmed that the tip did not fall into the patient during the procedure.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: FLAT NOSE DISSECTOR INSERT
• 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: 23247294
• Report Number: 1923569-2025-00013
• Device Sequence Number: 16011669
• Product Code: GCJ
• UDI-Device Identifier: 10885403171710
• UDI-Public: (01)10885403171710(10)E24
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 10/08/2025

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: SP8341
• Device Catalogue Number: SP8341
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 12/18/2025; 01/07/2026
• 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