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

Model Number	CV1186
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their cosgrove clamp broke and fell into the patient.The doctor was able to retrieve the pieces.No report of injury.
Additional Manufacturer Narrative
Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.
Additional Manufacturer Narrative
The cosgrove clamp subject of the reported event was not returned for evaluation; however, user facility personnel provided photos of the device.Photos of the device were evaluated and determined from the lot code that the cosgrove clamp is approximately 20 years old.Further evaluation of the photos showed that there was a broken cable wire with beads/pieces of the device contained within a plastic bag.Based solely on the provided pictures, the age and condition of the device cannot be eliminated as a cause of the reported event.The instructions for use state, "the cosgrove flex clamp should be inspected carefully prior to each use and during the cleaning procedure for any signs of unusual wear, cracking or corrosion.Inspect internal cable for kinking, fraying or any damage to the cable.Do not use if any irregularity is detected.".

• Brand Name: V. MUELLER
• Common Device Name: COSGROVE CLAMP
• Manufacturer (Section D): STERIS CORPORATION; 5 sunnen dr; saint louis MO 63143
• Manufacturer (Section G): STERIS CORPORATION; 5 sunnen dr; saint louis MO 63143
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20526643
• Report Number: 1923569-2024-01015
• Device Sequence Number: 20829144
• Product Code: DXC
• UDI-Device Identifier: 10885403036293
• UDI-Public: (01)10885403036293(F01)
• 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,Followup
• Report Date (Section B): 10/24/2024

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: CV1186
• Device Catalogue Number: CV1186
• Device Lot Number: (10)F01
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 02/21/2025; 02/24/2025
• 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