MAUDE Adverse Event Report: CAREFUSION INC. COSGROVE FLEX CLAMP QUICK BEND

Model Number	CV1161
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure the handle to their cosgrove flex clamp broke.User facility personnel utilized another clamp for the remainder of the procedure.After some period of time post-procedure, the patient was reported to have expired.
Additional Manufacturer Narrative
The user facility confirmed that the cosgrove flex clamp handle breaking did not cause or contribute to the patient's death.The patient at the time of the reported event suffered from multiple preexisting conditions.The device subject of the reported event is being returned for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The device subject of the reported event was returned for evaluation.The lot code was identified on the device which confirmed the device was approximately 20 years old.During evaluation of the device, it was found that the cable wires were frayed.The frayed ends were noted to be severed in a manner indicative of excessive and/or heavy forces.It is likely that the clamp was over stressed beyond its limits when actuated.The damage the device sustained may also be attributed to the age of the device, repeated twisting and crimping forces, or lack of maintenance to the device.Due to the damage and the age of the device, the cosgrove flex clamp was discarded and not returned to the customer.The instructions for use state that, "1.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.2.The instrument should be properly lubricated (milked) prior to sterilization.This will ensure smooth functioning of the device.3.For future issues it is recommended to replace or repair the parts of other cosgrove flex clamp products, by sending to the authorized northfield medical repairs center.The swaged cable fitting is a replaceable item." no additional issues have been reported.

• Brand Name: COSGROVE FLEX CLAMP QUICK BEND
• Common Device Name: COSGROVE FLEX CLAMP QUICK BEND
• Manufacturer (Section D): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION INC.; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 18241947
• Report Number: 1423507-2023-01004
• Device Sequence Number: 17784862
• Product Code: DXC
• UDI-Device Identifier: 10885403036286
• UDI-Public: 10885403036286
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 11/30/2023

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: CV1161
• 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: 11/02/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/14/2024
• 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