MAUDE Adverse Event Report: CAREFUSION INC. L-HOOK CAUTERY TIP; L HOOK ELECTRODE

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	10/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of event stated on medwatch (b)(4) is (b)(6) 2022.V.Mueller received medwatch (b)(4) on (b)(6) 2023.V.Mueller contacted the initial reporter listed on the subject medwatch report who was able to confirm the date of event listed on the medwatch report.The initial reporter stated that the subject device was not available for evaluation or return.Without return of the subject device, v.Mueller is unable to determine a root cause.The initial reporter further confirmed that the patient subject of the reported event did not obtain any injuries and was fine following the event.Personnel present during the time of the reported event followed their processes for attempting to find the cautery tip.The initial reporter also stated that she did not provide the lot number within medwatch (b)(4) as it was unavailable at the time she completed the medwatch form.The instructions for use states: before using the instrument, read and follow the instructions for use.Keep in a place where they can be easily seen for reference at a later date.The instruments should always be examined for correct assembly and function, surface damage, tears, and bent or worn parts.Damaged or defective instruments or individual parts may no longer be used.A follow-up report will be submitted should additional information become available.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch (b)(4) that during a patient procedure, the surgeon removed the l-hook and the nurse observed the cautery tip was no longer in place.An abdominal x-ray was taken of the patient following the procedure and no issues were noted.No injuries were reported.

• Brand Name: L-HOOK CAUTERY TIP
• Common Device Name: L HOOK ELECTRODE
• 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: 18062260
• Report Number: 1423507-2023-00105
• Device Sequence Number: 7527870
• Product Code: GEI
• UDI-Device Identifier: 10885403040351
• UDI-Public: 10885403040351
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 11/02/2023

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
• 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: Not provided
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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