FDA Adverse Event Malfunction Summary report: N

MAMMOTOME CONTROL MODULE WITH SMARTVAC - 120V

MDR report key: 1122053 · Received August 14, 2008

Report

Report Number: 3005075853-2008-01237
Event Type: Malfunction
Date Received: August 14, 2008
Date of Event: August 5, 2008
Report Date: August 5, 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: LA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND FOUND THE UNIBOARD WAS CAUSING THE UNIT TO HAVE BLUE CABLE ERRORS PER THE CUSTOMER COMPLAINT. TO CORRECT THE COMPLAINT, THE ANALYSIS SITE REPLACED THE UNIBOARD. PER THE SERVICE MANUAL, SERVICE TEST WERE PERFORMED WITH NO FUNCTIONAL FAULTS FOUND. AS PART OF THE STANDARD SERVICE PROCESS, REPLACED THE MUFFLER AND APPLIED DOW CORNING LUBRICANT TO THE DC MOTORS. 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 THE PROBE INITIALIZED FINE BUT GAVE A BLUE CABLE ERROR DURING THE FIRST SAMPLE OF A BREAST BIOPSY PROCEDURE. THE UNIT WAS RESET, ANOTHER ATTEMPT TO TAKE A SAMPLE WAS TAKEN AND NO SAMPLE WAS ABLE TO BE RETURNED. THE PROBE WAS SWAPPED WITH A SECOND PROBE AND THE CASE WAS COMPLETED WITH NO PT CONSEQUENCE. ONE DEVICE TO BE RETURNED FOR ANALYSIS BY CUSTOMER.

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				PROBE\| HOLSTER