MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; OCHSNER ARTERY FORCEPS

Model Number	SU2804
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that a tip from their ochsner artery forceps broke off during a patient procedure.The broken tip did not contact the patient, and the procedure was completed successfully.User facility personnel confirmed via x-ray that the broken piece was not present in the patient.No report of injury.
Additional Manufacturer Narrative
The ochsner artery forceps subject of the reported event is being returned for evaluation.Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The ochsner artery forceps subject of the reported event was returned for evaluation and confirmed the break on the tip of the device.The breakage of the tip may be attributed to user facility personnel overstressing the instrument during use subsequently causing the reported event to occur.User facility personnel were counseled on the proper use and handling of the ochsner artery forceps and the importance of not applying excessive pressure/stress to the tip of the instrument.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: V. MUELLER
• Common Device Name: OCHSNER ARTERY FORCEPS
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor 44060
• Manufacturer (Section G): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 22292298
• Report Number: 1527821-2025-00009
• Device Sequence Number: 12855520
• Product Code: GEN
• UDI-Device Identifier: 10885403064609
• UDI-Public: (01)10885403064609(10)K23XMR
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/19/2025

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: SU2804
• Device Catalogue Number: SU2804
• Device Lot Number: (10)K23XMR
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 10/01/2025
• 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