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

Model Number	SP90-6366
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their crocodile grasper came apart.The procedure was completed successfully using a different device following a short delay.No report of injury.
Additional Manufacturer Narrative
The crocodile grasper subject of the reported event was returned for evaluation.Evaluation results determined that the pin securing the jaws to the actuating rod was broken, with a portion of the pin remaining lodged within the pin hole.This breakage is not indicative of normal use.The damaged component is most likely attributed from mechanical overstress which allowed the pin component to separate from the device.The crocodile grasper instructions for use states, "avoid mechanical shock overstressing the devices; this will cause damage." steris provided in-service training on the proper use and operation of the crocodile grasper.The device history record for the subject lot was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: CROCODILE GRASPER
• 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: 25693337
• Report Number: 1923569-2026-00005
• Device Sequence Number: 9443610
• Product Code: GEI
• UDI-Device Identifier: 10885403159497
• UDI-Public: (01)10885403159497(10)SP906366
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K930666
• 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
• Report Date (Section B): 07/02/2026

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: SP90-6366
• Device Catalogue Number: SP906366
• Device Lot Number: (10)SP906366
• 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: 06/02/2026
• Initial Report FDA Received Date: 07/02/2026
• 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