FDA Adverse Event Malfunction Summary report: N

LIGAMAX-5MM

MDR report key: 1933071 · Received December 20, 2010

Report

Report Number: 3005075853-2010-07260
Event Type: Malfunction
Date Received: December 20, 2010
Date of Event: October 20, 2010
Report Date: October 25, 2010
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: OK, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4) = LOCKOUT FIRED TROUGH ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: (B)(4). THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RETURNED EMPTY AND WITH THE LOCK OUT MECHANISM BROKEN AS IT WAS FIRED THROUGH. THE INSTRUMENT IS DESIGNED TO LOCK OUT AFTER ALL THE CLIPS HAVE BEEN FIRED; THEREFORE A POTENTIAL CAUSE OF THE CUSTOMER REPORTED EXPERIENCE IS THE FIRING OF ALL OF THE CLIPS AND THE INSTRUMENT "WOULD NOT FIRE" (ACTIVATION OF THE LOCK OUT MECHANISM). THE INSTRUMENT HAS AN ORANGE INDICATOR THAT APPEARS ON THE TOP OF THE HANDLE AS A REFERENCE FOR THE USER AS TO THE QUANTITY OF CLIPS REMAINING. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS USED SEVERAL TIMES WITH NO ISSUES. THERE WAS A BLEEDER THAT THE SURGEON ATTEMPTED TO CLIP AND NO CLIP CAME OUT. THE CLIP WAS JAMMED SO THE SURGEON ATTEMPTED TO CLIP THE BLEEDER AGAIN AND NO CLIP CAME OUT. AN ENDO LOOP WAS USED TO CLIP THE BLEEDER AND TO COMPLETE THE PROCEDURE. THERE WAS APPROXIMATELY A MINIMAL AMOUNT OF BLOOD LOSS. NO ADVERSE CONSEQUENCES REPORTED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1