FDA Adverse Event Malfunction Summary report: N

LIGAMAX CLIP APPLIER

MDR report key: 3953173 · Received July 23, 2014

Report

Report Number: 3005075853-2014-05175
Event Type: Malfunction
Date Received: July 23, 2014
Date of Event: July 11, 2014
Report Date: July 14, 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: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION: DRIED BODY FLUIDS. THE EL5ML DEVICE WAS RECEIVED FOR ANALYSIS PARTIALLY FIRED WITH A CLIP IN THE JAW. UPON VISUAL INSPECTION, EXCESSIVE DRIED BODY FLUIDS WERE FOUND ON THE INSTRUMENT. THE CYCLE WAS COMPLETED AND ONE CONFORMING CLIP WAS FORMED; IN THE NEXT ACTUATION OF THE TRIGGER, A DOUBLE FEED INCIDENT OCCURRED DUE TO THE EXCESSIVE DRIED BODY FLUIDS. THE DEVICE WAS CYCLED AND THREE CONFORMING CLIPS WERE FED AND FORMED; FINALLY THE INSTRUMENT LOCKED OUT AS INTENDED. ACCUMULATION OF BODY FLUIDS IS A ROUTINE OCCURRENCE DURING SURGICAL PROCEDURES AND DOES NOT NECESSARILY INDICATE A MANUFACTURING DEFECT IN THE DEVICE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

Additional Manufacturer Narrative · 1

(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, AFTER FIRING THE DEVICE WAS LOCKED AND WOULD NOT UNLOCK. IT WAS UNKNOWN IF THE DEVICE WAS ON TISSUE AT THE TIME. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
431557	LIGAMAX CLIP APPLIER	CLIP, IMPLANTABLE	FZP	ETHICON ENDO-SURGERY, LLC.	NA	L4EN06

Patients

Seq	Age	Sex	Outcome	Treatment
1