FDA Adverse Event Injury Summary report: N

LIGASURE V SEALER/DIVIDER

MDR report key: 3893995 · Received June 16, 2014

Report

Report Number: 1717344-2014-00510
Event Type: Injury
Date Received: June 16, 2014
Report Date: June 10, 2014
Manufacturer: COVIDIEN LP
Product Code: GEI
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS TESTED ON SIMULATED TISSUE FOR ACTIVATION AND KNIFE FUNCTION. THE DEVICE FUNCTIONED NORMALLY WHEN ACTIVATED BUT THE KNIFE WOULD NOT CUT SMOOTHLY. EXAMINATION UNDER MAGNIFICATION CONFIRMED DAMAGE TO THE LEADING EDGE OF THE BLADE. THE BLADE WAS FOUND TO HAVE 0.04 INCHES BROKEN AND MISSING. IT IS POSSIBLE THE CUSTOMER HIT A STAPLE, METAL PIN OR OTHER HARD SUBSTANCE THAT DAMAGED THE BLADE. THE IFU FOR THIS PRODUCT HAS A WARNING NOT TO DEPLOY THE CUTTER ON CLIPS, STAPLES AND OTHER METAL OBJECTS TO PREVENT DAMAGE TO THE CUTTER BLADE. THE IFU ALSO RECOMMENDS CLEANING THE JAWS WITH A PIECE OF WET GAUZE TO HELP MINIMIZE TISSUE BUILD-UP BETWEEN THE JAWS.

Description of Event or Problem · 1

THE CUSTOMER ORIGINALLY REPORTED, THE LS1500 DEVICE WAS DEFECTIVE, NO ADDITIONAL DETAILS WERE MADE AVAILABLE FROM THE SITE. WHEN THE DEVICE SAMPLE WAS RECEIVED FOR INVESTIGATION ON (B)(4) 2014, IT WAS NOTED THAT THERE WAS DAMAGE TO THE KNIFE BLADE EDGE AND .04 INCHES OF THE BLADE WAS MISSING. THE SITE WAS CONTACTED REGARDING THE MISSING KNIFE COMPONENTS, BUT TO DATE, HAS NOT BEEN ABLE TO CONFIRM THE LOCATION OF THE MISSING COMPONENTS. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
353465	LIGASURE V SEALER/DIVIDER	LIGASURE VESSEL SEALING SYSTEM	GEI	COVIDIEN LP		S4BB015RAX

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other