MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; FORCEP

Model Number	RH551-111
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event is being returned for evaluation.Investigation of the reported event is in progress.A follow-up report will be submitted once 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.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch report (b)(4) that during a patient procedure a piece of their weil-blakesly forcep broke.The piece was successfully retrieved from the patient and the procedure was completed successfully with another device.No report of injury or procedure delay.
Additional Manufacturer Narrative
The device subject of the reported event was returned to the supplier for evaluation.Upon evaluation, it was discovered that the upper jaw of the forcep was broken.The cause of the reported event was attributed to user facility personnel overstressing the device during use.The weil-blakesly forcep ifu states, "avoid mechanical shock or overstressing the devices.Close distal ends prior to insertion or removal through cannulas." steris offered in-service training on the proper use and operation of the weil blakesly forcep, specifically on not overstressing the device, 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: V. MUELLER
• Common Device Name: FORCEP
• 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: 22482777
• Report Number: 1527821-2025-00011
• Device Sequence Number: 8554959
• Product Code: KAE
• UDI-Device Identifier: 10885403110221
• UDI-Public: (01)10885403110221(10)C22VIN
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/11/2025

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: RH551-111
• Device Catalogue Number: RH551111
• Device Lot Number: (10)C22VIN
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 11/25/2025
• 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