FDA Adverse Event Malfunction Summary report: N

LIGAMAX 5MM

MDR report key: 3896641 · Received June 26, 2014

Report

Report Number: 3005075853-2014-04424
Event Type: Malfunction
Date Received: June 26, 2014
Date of Event: May 13, 2014
Report Date: May 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: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RETURNED EMPTY. THE ANALYSIS RESULTS FOUND THAT THE EL5ML DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. UPON CYCLING THE DEVICE, IT WAS NOTED TO BE EMPTY AND LOCKED OUT, HOWEVER THE ORANGE INDICATOR DID NOT SHOW UP. PLEASE NOTE THAT THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. THE INSTRUMENT IS DESIGNED TO LOCK OUT AFTER ALL THE CLIPS HAVE BEEN FIRED. IN ADDITION, 6 CLIPS CONFORMING AND 3 MALFORMED CLIPS WERE RECEIVED IN A PLASTIC BAG. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE EVENT REPORTED. 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 LAP CHOLECYSTECTOMY, CLIPS FED INTO THE JAWS AT A TIME AFTER SEVERAL FIRINGS. IT WAS UNKNOWN WHICH FIRING OF THE DEVICE THIS EVENT OCCURRED ON. THE DEVICE WAS USED ON THE BLOOD VESSEL. THE DEVICE DID NOT CLAMP SOMETHING HARD SUCH AS AN EXISTING CLIP. THERE WAS NO UNEXPECTED NOISE. AFTER THE EVENT, THE DEVICE WAS FIRED SEVERAL TIMES OUT OF THE PATIENT AND THE SAME EVENT WAS RECREATED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
373635	LIGAMAX 5MM	CLIP, IMPLANTABLE	FZP	ETHICON ENDO-SURGERY, LLC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1