MAUDE Adverse Event Report: CAREFUSION INC. GEMINI ARTERY FORCEPS

Model Number SU10530

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2023

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 332919318
• Report Number: 1423507-2024-01001
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 10885403065323
• UDI-Public: 10885403065323
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: SU10530
• Device Lot Number: 78632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1