FDA Adverse Event Malfunction Summary report: N

MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V

MDR report key: 1100045 · Received August 5, 2008

Report

Report Number: 3005075853-2008-00920
Event Type: Malfunction
Date Received: August 5, 2008
Date of Event: June 17, 2008
Report Date: June 18, 2008
Manufacturer: ETHICON ENDO-SURGERY, LLC
Product Code: KNW
PMA / PMN Number: K991980
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVAL SUMMARY: BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE AN MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER'S COMPLAINT AND FOUND THE UNIBOARD WAS CAUSING THE UNIT TO HAVE L4-005 ERROR AND CONSTANTLY REBOOTING. TO CORRECT THE CUSTOMER'S COMPLAINT, THE ANALYSIS SITE REPLACED THE UNIBOARD AND PER SVC MANUAL PERFORMED SVC TESTS WITH NO FUNCTIONAL FAULTS FOUND. AS PART OF THE STANDARD SVC PROCESS REPLACED THE MUFFLER AND APPLIED DOW CORNING LUBRICANT TO THE DC MOTORS. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND HAS PASSED QA INSPECTION. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT PRIOR TO STARTING A MAMMOTOME BIOPSY PROCEDURE, THE CAPITAL EQUIPMENT WAS TURNED ON AND AN ERROR CODE L4-005 APPEARED ON THE SCREEN AND COULD NOT BE REMOVED. A DEMO UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE. ONE DEVICE WILL BE RETURNED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V		KNW	ETHICON ENDO-SURGERY, LLC	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1				HOLSTER\| PROBE