FDA Adverse Event Malfunction Summary report: N

LIGAMAX CLIP APPLIER

MDR report key: 3833248 · Received May 27, 2014

Report

Report Number: 3005075853-2014-03557
Event Type: Malfunction
Date Received: May 27, 2014
Date of Event: March 27, 2014
Report Date: April 2, 2014
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: FZP
PMA / PMN Number: K050344
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RESULTS: DRIED BODILY FLUIDS, CLIP GAP. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED IN GOOD VISUAL CONDITION. UPON EVALUATION THE TRIGGER WAS DIFFICULT TO CYCLE; IN ADDITION, ONE GAP CLIP WAS FIRED FROM THE DEVICE. IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS OF THE DEVICE, IT WAS DISASSEMBLED. UPON DISASSEMBLING, EXCESSIVE DRIED BODY FLUIDS WERE NOTED IN THE SHAFT ASSEMBLY. IT IS POSSIBLE THAT THE DRIED BODY FLUIDS COULD HAVE PREVENTED TO PROPER FEEDING OF THE CLIP INTO THE JAW, WHICH HAVE CAUSED THE CLIP GAP CONDITION FOUND. ACCUMULATION OF BODY FLUIDS IS A ROUTINE OCCURRENCE DURING SURGICAL PROCEDURES AND DOES NOT NECESSARILY INDICATE A MANUFACTURING DEFECT IN THE DEVICE. DUE TO THE CONDITION OF THE DEVICE, NO FUNCTIONAL TESTING COULD BE PERFORMED TO EVALUATE THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WOULD NOT FIRE. IT WAS UNKNOWN WHICH FIRING THIS OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
310628	LIGAMAX CLIP APPLIER	CLIP, IMPLANTABLE	FZP	ETHICON ENDO-SURGERY, LLC.	NA	L4E95P

Patients

Seq	Age	Sex	Outcome	Treatment
1