FDA Adverse Event Malfunction Summary report: N

LIGAMAX-5MM

MDR report key: 1913691 · Received December 3, 2010

Report

Report Number: 3005075853-2010-06828
Event Type: Malfunction
Date Received: December 3, 2010
Date of Event: September 27, 2010
Report Date: September 28, 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: LA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). JAWS DISENGAGED. THE ANALYSIS RESULTS OF THE DEVICE FOUND THAT IT WAS RECEIVED INSERTED THROUGH AN ENDOPATH XCEL TROCAR AND WITH ONE JAW DISENGAGED FROM THE CAM. THIS CONDITION WOULD NOT ALLOW THE JAWS TO COLLAPSE IN ORDER TO FORM THE CLIPS AND BE REMOVED FROM THE TROCAR. THE DEVICE WAS CYCLED AND EJECTED THE REMAINING CLIPS DUE TO THE FOUND CONDITION. POSSIBLE CAUSES FOR THE FOUND CONDITION OF THE JAWS MAY BE INADVERTENT FORCE, TWISTING OR PRESSURE BEING PLACED ON THE DEVICE JAWS, USING THE JAWS OF THE DEVICE AS A DISSECTOR/RETRACTOR OR DAMAGE TO THE JAWS WHILE ENTERING THE TROCAR. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS OVER-TRAVELED. THIS FINDING IS NOT RELATED TO THE REPORTED EVENT. 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 LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE THE CLIPS WERE MALFORMED. WHEN THEY TRIED TO REMOVE THE DEVICE THE JAWS WOULD NOT CLOSE SO THEY REMOVED THE DEVICE AND THE TROCAR TOGETHER. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.

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