FDA Adverse Event Malfunction Summary report: N

LIGACLIP** ENDOSCOPIC CLIP APPLIER

MDR report key: 3051344 · Received April 10, 2013

Report

Report Number: 3005075853-2013-01714
Event Type: Malfunction
Date Received: April 10, 2013
Date of Event: March 5, 2013
Report Date: March 18, 2013
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: FZP
PMA / PMN Number: K864102
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: WHICH FIRING OF THE DEVICE DID THIS EVENT OCCUR ON? 1ST AND 2ND. WHAT VESSEL OR STRUCTURE WAS THE DEVICE FIRED ON AT THE TIME OF THE EVENT? NA. WAS THE CLIP FULLY ADVANCED INTO THE JAWS PRIOR TO FIRING? YES. WAS THERE ANY TORQUING OR TWISTING OF THE DEVICE PRESENT AT THE TIME OF FIRING? NO. WAS ANY UNEXPECTED RESISTANCE FELT WHILE FIRING THE TRIGGER? NO. WERE ANY UNEXPECTED NOISES HEARD? NO. DID ANYTHING UNEXPECTED HAPPEN PRIOR TO THIS INCIDENT? NA. WAS THE DEVICE FIRED AFTER THIS INCIDENT IN OR OUT OF THE PATIENT? OUT. DID SOMEBODY OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? NO.

Description of Event or Problem · 1

HIT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE DEVICE WAS FIRED PRE OP FOR TESTING AND THE CLIPS WERE EJECTING OUT OF THE DEVICE AND WERE MALFORMED. THEY USED THE DEVICE TO COMPLETE THE PROCEDURE ONCE THOSE CLIPS CLEARED. THERE WAS NO REPORTED CONSEQUENCE TO THE PATIENT. USER FACILITY MEDWATCH# (B)(4) ATTACHED TO THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
153009	LIGACLIP** ENDOSCOPIC CLIP APPLIER	CLIP, IMPLANTABLE	FZP	ETHICON ENDO-SURGERY, LLC.	NA	K4C293

Patients

Seq	Age	Sex	Outcome	Treatment
1