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

Model Number	SP8341
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was returned to steris for evaluation.Upon evaluation, it was discovered that the pin joining the jaw to the rod-link was broken which is indicative of excess force by user facility personnel.The cause of the reported event was attributed to user error.The flat nose dissector ifu states, "avoid mechanical shock or overstressing the devices; this will cause damage." a complaint review was performed and confirmed this to be an isolated event for the subject lot.Steris offered in-service training on the proper use and operation of the flat nose dissector, specifically on not overstressing the device, however the user facility declined.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure the tip of their flat nose dissector broke.The procedure was completed successfully using a different device following a short delay.No report of injury.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: DISSECTOR
• 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: 23610647
• Report Number: 1923569-2025-00014
• Device Sequence Number: 18621301
• Product Code: GCJ
• UDI-Device Identifier: 10885403171710
• UDI-Public: (01)10885403171710(10)H25
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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)H25
• 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: 10/21/2025
• Initial Report FDA Received Date: 11/20/2025
• 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