FDA Adverse Event Malfunction Summary report: N

MAMMOTOME CONTROL MODULE WITH SMARTVAC - 20/240V

MDR report key: 1829064 · Received January 3, 2008

Report

Report Number: 1527736-2008-00067
Event Type: Malfunction
Date Received: January 3, 2008
Date of Event: November 16, 2007
Report Date: November 26, 2007
Manufacturer: ETHICON ENDO SURGERY, INC. (CINCINNATI)
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

(B)(4). EVAL SUMMARY: THE UNIT WAS RETURNED TO THE ANALYSIS SITE DUE TO L3-021, L3-010 ERROR CODES SHOWED ON THE SCREEN AND MADE LOTS OF UN-COMMON NOISES. THE ANALYSIS SITE PER THE MAMMOTOME SERVICE MANUAL PERFORMED SERVICE TESTS AND FOUND THE VSO WAS CAUSING THE UNIT TO HAVE THE ERROR L3-021 (VACUUM ERROR) AND DISTORTED THE SPEAKER CAUSING ERRATIC NOISES CONFIRMING THE CUSTOMER COMPLAINT. TO CORRECT THIS ISSUE THE SITE REPLACED THE VSO AND THE SPEAKER ASSEMBLY. THE ANALYSIS SITE COULD NOT DUPLICATE THE CUSTOMER COMPLAINT OF ERROR L3-010 DURING TESTING. AS PART OF THE STANDARD EES SERVICE PROCESS, REPLACED THE MUFFLER, APPLIED LOCTITE TO THE HAND/FOOT SWITCH CONNECTOR, AND APPLIED DOW CORNING LUBRICANT TO THE DC MOTORS. THE UNIT HAS NOT BEEN RETURNED FOR SERVICE PRIOR TO THIS EVENT, THEREFORE NO SERVICE HISTORY REVIEW CAN BE DONE.

Description of Event or Problem · 1

IT WAS REPORTED THAT BEFORE SURGERY, UNIT TEST WAS OK BUT DURING THE SURGERY L3-021, 010 SHOWED ON THE SCREEN AND MADE LOTS OF UNCOMMON NOISES. PROCEDURE: BREAST BIOPSY. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MAMMOTOME CONTROL MODULE WITH SMARTVAC - 20/240V		KNW	ETHICON ENDO SURGERY, INC. (CINCINNATI)	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1				HOLSTER\| PROBE