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

Model Number	CV5050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their fogarty hydragrip clamp broke.Another clamp was used to complete the procedure which resulted in a short delay.No report of injury.
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.
Additional Manufacturer Narrative
The device subject of the reported event was returned to steris for evaluation; however, an exact cause of the reported event could not be determined.The device subject of the reported event was manufactured in 1988 and is approximately 37 years old.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.Udi related data clarification - the device subject of the event was manufactured prior to udi compliance, therefore, udi is not applicable and was not included in the mdr.

• Brand Name: V.MUELLER
• Common Device Name: CLAMP
• 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: 22482347
• Report Number: 1923569-2025-00009
• Device Sequence Number: 8668676
• Product Code: DXC
• UDI-Device Identifier: 10885403036354
• UDI-Public: (01)10885403036354
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K951413
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CV5050
• Device Catalogue Number: CV5050
• Device Lot Number: NC
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/1988
• 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