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

Model Number	SP90-6343
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
Investigation of the reported event is in progress.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure their debakey clamp broke at the tip.The procedure was completed successfully using a different device following a short delay.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 jaw of the device had broken off.Based on the evaluation, the cause of the reported event was attributed to user facility personnel overstressing the device.The debakey clamp ifu states, "avoid mechanical shock or overstressing the devices." steris offered in-service training on the proper use and operation of the debakey clamp; however, the user facility declined.A 2-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: CLAMP
• 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: 23610659
• Report Number: 1923569-2025-00015
• Device Sequence Number: 13076113
• Product Code: GEI
• UDI-Device Identifier: 10885403159268
• UDI-Public: (01)10885403159268(10)G22
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 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: SP90-6343
• Device Catalogue Number: SP906343
• Device Lot Number: (10)G22
• 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
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/18/2025
• 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