FDA Adverse Event Malfunction Summary report: N

LIGAMAX-5MM ENDO CLIP APPLIER

MDR report key: 1925416 · Received December 14, 2010

Report

Report Number: 3005075853-2010-07089
Event Type: Malfunction
Date Received: December 14, 2010
Date of Event: November 18, 2010
Report Date: November 22, 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: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS AS INTENDED. THE CLIPS WERE EVALUATED WITH THE FUNNEL GAGE AND THEY WERE CONFORMING ACCORDING TO OUR MANUFACTURING SPECIFICATIONS. IN ADDITION, THE DEVICE LOCKED OUT AS INTENDED BUT THE ORANGE INDICATOR WAS VISIBLE AT THE 12TH FIRING SEQUENCE THUS, IT OVER TRAVELED. THIS FINDING IS NOT RELATED WITH THE INCIDENT REPORTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

Additional Manufacturer Narrative · 1

(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

Additional Manufacturer Narrative · 1

(B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PROSTATECTOMY PROCEDURE AFTER SEVERAL MALFORMED CLIPS THE DEVICE LOCKED ITSELF. 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 ENDO CLIP APPLIER	CLIP, IMPLANTABLE	FZP	ETHICON ENDO-SURGERY, LLC.	NA	G4TX92

Patients

Seq	Age	Sex	Outcome	Treatment
1