MAUDE Adverse Event Report: CAREFUSION INC. GEMINI ARTERY FORCEPS

Model Number	SU10530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The gemini artery forceps subject of the reported event have been returned for evaluation.Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure the tip of the gemini artery forceps broke off.The tip was observed to be on the surgical table.User facility personnel took an x-ray of the patient and confirmed no pieces of the instrument to be present.The procedure was completed successfully, and no injuries were reported.
Additional Manufacturer Narrative
The gemini artery forceps were returned for evaluation.While a definitive root cause could not be confirmed, it was noted during the evaluation that the material of one of the jaws appeared thinner than expected.The supplier was made aware of the event.The device history record (dhr) for the subject lot was reviewed and no abnormalities were identified.A complaint review confirms this to be an isolated event.No additional issues have been reported.

• Brand Name: GEMINI ARTERY FORCEPS
• Common Device Name: GEMINI ARTERY FORCEPS
• 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: 18499849
• Report Number: 1423507-2024-01001
• Device Sequence Number: 8044764
• Product Code: GEN
• UDI-Device Identifier: 10885403065323
• UDI-Public: 10885403065323
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 01/11/2024

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: SU10530
• Device Lot Number: 78632
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 03/12/2024
• 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