MAUDE Adverse Event Report: ETHICON (JOHNSON & JOHNSON); LIGACLIP IN DBD-LAP CHOLE PACK

Catalog Number	DYNJ58220
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a laparoscopic cholecystectomy, the ethicon ligaclip pack component misfired and fell into the surgical site.The surgeon was required to retrieve the misfired ethicon ligaclip from the surgical site via an unidentified method.The patient was under general anesthesia at the time of this incident.Reportedly, the incident added approximately fifteen (15) minutes to the overall procedure time.The patient did not require additional anesthesia and no further incident was reported.No impact to the patient, the patient's stability, or the patient's plan of care was reported.No serious injury or follow-up care reported.A sample was returned for evaluation.(b)(4) is the manufacturer of this device.(b)(4).Has been notified and will conduct an investigation and make the determination whether any corrective action is indicated.Due to the need for medical intervention to retrieve the misfired ethicon ligaclip from the surgical site, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a laparoscopic cholecystectomy, the ethicon ligaclip pack component misfired and fell into the surgical site.

• Common Device Name: LIGACLIP IN DBD-LAP CHOLE PACK
• Manufacturer (Section D): ETHICON (JOHNSON & JOHNSON); one johnson & johnson plaza; new brunswick NJ 08901 1241
• MDR Report Key: 7822443
• Report Number: 1423395-2018-00048
• Device Sequence Number: 19129703
• Product Code: FDE
• UDI-Device Identifier: 10889942835799
• UDI-Public: 10889942835799
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2018

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 Catalogue Number: DYNJ58220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 94