MAUDE Adverse Event Report: STERIS CORPORATION SNOWDEN-PENCER; MIS DIAMOND-FLEX TRIANGULAR RETRACTOR

Model Number	89-6112
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the event is currently in progress.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 via medwatch (b)(4)that during surgery, the liver retractor did not straighten out completely upon removal and abraded the left lobe of the liver creating some discharge.Surgical powder and a hemostatic agent were used; the surgeon was able to gain hemostasis.The instrument was tagged and sent to csp and did not find any malfunction.The user facility stated the patient did not suffer ongoing issues and did not require an extended stay.
Additional Manufacturer Narrative
The device subject of the event was returned for evaluation.The evaluation found evidence that the memory wire was bent and there was a sharp edge on the main shaft of the device.The dhr for the lot subject of the event was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.A complaint review confirmed this to be an isolated event for the subject lot.Based on the evaluation results, the reported event was likely caused by the sharp edge when the bent device was removed from the patient.The damage observed to the device is indicative of improper handling by user facility personnel, specifically not using the protective sterilizing sleeve for the device during sterilization and storage.The instructions for use states, "when sterilizing or storing device, always use protective sterilizing sleeve provided.Failure to use the sleeve may result in premature device failure.This device should never be folded or bent to fit into a small sterilization tray.Prior to use, inspect device to ensure proper function, insulation and condition.Do not use devices if they do not satisfactorily perform their intended function or have physical damage." a steris account manager provided in-service training on the proper use and operation of the retractor, specifically to use the protective sterilizing sleeve for the device during sterilization and storage.No additional issues have been reported.

• Brand Name: SNOWDEN-PENCER
• Common Device Name: MIS DIAMOND-FLEX TRIANGULAR RETRACTOR
• 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 ; 4402597401
• MDR Report Key: 22874517
• Report Number: 1923569-2025-00011
• Device Sequence Number: 17565090
• Product Code: GCJ
• UDI-Device Identifier: 10885403122835
• UDI-Public: (01)10885403122835(10)C24
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K092684
• 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): 08/22/2025

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: 89-6112
• Device Catalogue Number: 896112
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/30/2025
• 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