MAUDE Adverse Event Report: STERIS CORPORATION SNOWDEN-PENCER; DISSECT SCISSORS

Model Number	32-5950
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in progress; a follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure the tip of their tebbetts dissect scissors broke.The procedure was completed successfully using a different device.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was returned to steris for evaluation.The evaluation revealed that the tip of the device had separated.This separation is not indicative of normal use.The damaged component is most likely attributed to excessive force.Additionally, the device was manufactured in 2007 and showed evidence of visible wear.The tebbetts dissect scissors, "avoid mechanical shock or overstressing the devices.Avoid overstressing mechanism of instruments by properly gripping and maneuvering during surgery.Instruments are designed to be held with one finger and thumb in ring handles.If force is applied in any other fashion (such as holding handles in a whole hand pistol grip), the mechanism can be easily overstressed resulting in damage or breakage.Proper care and handling is essential for satisfactory performance of any surgical device.The previous cautions should be taken to ensure long and trouble-free service from all your surgical devices.Inspect devices before each use for broken, cracked, tarnished surfaces, movement of hinges, and chipped or worn parts.If any of these conditions appear, do not use the device.Return devices to an authorized repair service center, such as steris ims, for repair or replacement." steris offered in-service training on the proper use and operation of the tebbetts dissect scissors; however, the user facility declined.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: DISSECT SCISSORS
• Manufacturer (Section D): STERIS CORPORATION; 5 sunnen drive; maplewood MO
• 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: 23881542
• Report Number: 1923569-2025-00016
• Device Sequence Number: 9464759
• Product Code: LRW
• UDI-Device Identifier: 10885403148576
• UDI-Public: (01)10885403148576(10)C07
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 12/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 32-5950
• Device Catalogue Number: 325950
• Device Lot Number: (10)C07
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 05/22/2026
• 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