FDA Adverse Event Malfunction Summary report: N

LIGACLIP**

MDR report key: 1821651 · Received August 31, 2010

Report

Report Number: 3005075853-2010-04970
Event Type: Malfunction
Date Received: August 31, 2010
Date of Event: August 2, 2010
Report Date: August 5, 2010
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: FZP
PMA / PMN Number: K830503
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: ID, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE ANALYSIS RESULTS CONFIRMED THAT INSTRUMENT (A) WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS LOADED, RETAINED, AND FORMED THE CLIPS PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE ANALYSIS RESULTS CONFIRMED THAT INSTRUMENT (B) WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS LOADED, RETAINED, AND FORMED THE CLIPS PROPERLY. THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO DESIGN SPECIFICATIONS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. DEVICE B LOT # 5101A213. DUE TO THE LOT OF BOTH DEVICES BEING FROM 1996, THEY HAVE EXCEED OUR RECORD RETENTION POLICY. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES.

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, CLIPS ARE NOT HOLDING. NO OTHER DETAILS WERE PROVIDED. NO PATIENT IMPACT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LIGACLIP**	LIGACLIP*ENDO MED/LG APPLIER	FZP	ETHICON ENDO-SURGERY, LLC.	NA	5135A213

Patients

Seq	Age	Sex	Outcome	Treatment
1