FDA Adverse Event Malfunction Summary report: N

LAPRA-TY* ABSORBABLE CLIP APPLIER

MDR report key: 1915851 · Received December 6, 2010

Report

Report Number: 3005075853-2010-06896
Event Type: Malfunction
Date Received: December 6, 2010
Date of Event: November 1, 2010
Report Date: November 11, 2010
Manufacturer: ETHICON ENDO-SURGERY, LLC.
Product Code: GDO
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY TO EVALUATE ANY CLIP FORMATION ISSUES. UPON FUNCTIONAL TESTING OF THE DEVICE, THE INSTRUMENT LOADED, RETAINED AND DEPLOYED 6 CLIPS AS INTENDED OVER SUTURE. THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO OUR MANUFACTURING REQUIREMENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. 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.

Description of Event or Problem · 1

IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED ON THE FIRST INFLATION. THE DEVICE WAS REMOVED INTACT.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A LAPAROSCOPIC NISSEN PROCEDURE, THE DEVICE WOULD NOT LOCK THE TIE WHEN FIRED. IT IS UNKNOWN WHICH BASE WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LAPRA-TY* ABSORBABLE CLIP APPLIER		GDO	ETHICON ENDO-SURGERY, LLC.

Patients

Seq	Age	Sex	Outcome	Treatment
1