MAUDE Adverse Event Report: STERIS CORPORATION SNOWDEN-PENCER; CROCODILE SA ERGONOMIC MODULAR

Model Number	SP8364
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	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation into the reported event is in process.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 that during a patient procedure the distal end of their crocodile sa ergonomic modular "snapped off" creating a procedure delay.No report of injury.
Additional Manufacturer Narrative
The crocodile sa ergonomic modular subject of the reported event was returned for evaluation.Evaluation results determined that three pin components which hold the device together were missing from the device.This breakage is not indicative of normal use.The distal end detaching from the device is most likely attributed from excessive force which allowed the pins to separate from the device.The crocodile sa ergonomic modular instructions for use (ifu) states the following with regards to proper usage, "avoid mechanical shock or overstressing the devices; this will cause damage." steris offered in-service training on the proper use and operation of the crocodile sa ergonomic modular device; however, the user facility declined.The device history record was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: CROCODILE SA ERGONOMIC MODULAR
• 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 ; 4403927453
• MDR Report Key: 21770117
• Report Number: 1923569-2025-00005
• Device Sequence Number: 18597356
• Product Code: GCJ
• UDI-Device Identifier: 10885403171956
• UDI-Public: (01)10885403171956(10)C24
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 04/03/2025

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: SP8364
• Device Catalogue Number: SP8364
• Device Lot Number: (10)C24
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 06/05/2025
• 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