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

Model Number	CV5050
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
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 was returned to steris for evaluation; however, the exact cause of the reported event could not be determined.The device history record for the subject lot was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.A complaint review was conducted for this lot of products and confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: V.MUELLER
• Common Device Name: HYDRAGRIP 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 road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24969255
• Report Number: 1923569-2026-00004
• Device Sequence Number: 10428228
• Product Code: DXC
• UDI-Device Identifier: 10885403036354
• UDI-Public: (01)10885403036354(10)C25
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 04/23/2026

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: (10)C25
• 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: 03/24/2026
• Initial Report FDA Received Date: 04/23/2026
• 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