FDA Adverse Event Malfunction Summary report: N

LIGACLIP CLIP APPLIER

MDR report key: 4852816 · Received June 18, 2015

Report

Report Number: 3005075853-2015-03704
Event Type: Malfunction
Date Received: June 18, 2015
Date of Event: June 1, 2015
Report Date: June 1, 2015
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: FZP
PMA / PMN Number: K864102
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION: THE ER320 DEVICE WAS RETURNED FOR ANALYSIS AND UPON INSPECTION THE JAWS WERE FOUND TO BE IN A YIELDED CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT THE DEVICE WAS FUNCTIONALLY EVALUATED. UPON FIRING OF THE DEVICE, THE REMAINING CLIPS WERE DROPPED DUE TO THE CONDITION OF THE JAWS; FINALLY THE INSTRUMENT LOCKED OUT AS INTENDED. POSSIBLE CAUSES FOR THE FOUND CONDITION OF THE YIELDED JAWS MAY BE IF THE DEVICE IS CLOSED OVER AN EXISTING HARD OBJECT OR CLIP PLACING STRESS ON THE JAWS CAUSING THEM TO DISTORT OR YIELD AND NOT RETURN TO THEIR ORIGINAL DIMENSIONS/POSITION OR EXCESSIVE APPLICATION OF TORQUE TO THE JAWS WHEN POSITIONING THE DEVICE ON A VESSEL.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE FIRST 3 CLIPS FIRED AS EXPECTED. SUBSEQUENT CLIPS ALL CAME OUT SCISSORED AND HAD TO BE REMOVED OFF VESSEL. ANOTHER ER320 WAS OPENED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
396794	LIGACLIP CLIP APPLIER	CLIP, IMPLANTABLE	FZP	ETHICON ENDO-SURGERY, LLC.	NA	M4HD43

Patients

Seq	Age	Sex	Outcome	Treatment
1