MAUDE Adverse Event Report: STERIS CORPORATION V. MUELLER; TUBING CLAMP FORCEPS

Model Number	SU2857
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is 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 that during a patient procedure their tubing clamp forceps "broke into multiple pieces".User facility personnel stated that all pieces were immediately retrieved.No report of injury.
Additional Manufacturer Narrative
Steris made multiple attempts to contact the user facility for the return of the device however, the user facility did not respond.Without the return and evaluation of the subject device a root cause cannot be determined.No additional issues have been reported.

• Brand Name: V. MUELLER
• Common Device Name: TUBING CLAMP 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: 20788062
• Report Number: 1527821-2024-00022
• Device Sequence Number: 6989632
• Product Code: HXD
• UDI-Device Identifier: 10885403064753
• UDI-Public: (01)10885403064753
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/26/2024

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: SU2857
• Device Catalogue Number: SU2857
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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