FDA Adverse Event Malfunction Summary report: N

MTOME ST HOLSTER/CABLES

MDR report key: 1024215 · Received March 27, 2008

Report

Report Number: 1527736-2008-01892
Event Type: Malfunction
Date Received: March 27, 2008
Date of Event: March 7, 2008
Report Date: March 10, 2008
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: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

BASED ON ANALYSIS RESULTS, THIS COMPLAINT IS NOW DETERMINED TO BE A MDR MALFUNCTION. THE ANALYSIS SITE CONFIRMED THE CUSTOMER COMPLAINT AND FOUND THE GREEN ABLE WAS BROKEN AT THE CONNECTOR. TO CORRECT THE COMPLAINT, THE ANALYSIS SITE REPLACED THE GREEN CABLE. THE ANALYSIS SITE ALSO FOUND THERE WERE WIRES SHOWING THROUGH THE BLACK CABLE, AND TO CORRECT THIS ISSUE THE SITE REPLACED THE BLACK CABLE, AND THE BLUE CABLE WAS MAKING A LOUD GRINDING NOISE DURING TESTING AND TO CORRECT THIS ISSUE THE SITE REPLACED THE BLUE CABLE. THE SAFETY LATCH WAS REPLACED DUE TO IT WAS BENT AND CAUSING THE UNIT TO FIRE WHEN IN THE LOCKED POSITION, THE PORT SHAFT WAS REPLACED DUE TO IT WAS BENT AND THE E-CLIP WAS REPLACED DUE TO IT WAS DAMAGED DURING DISASSEMBLY. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND HAS PASSED QA INSPECTION. AFTER SERVICING, THE UNIT PASSED ALL QA FUNCTIONAL TESTING. COMPLAINT INFORMATION IS TRENDING ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT IT WAS NOTICED DURING A BREAST BIOPSY THAT THE GREEN CABLE CONNECTOR IS FRAYED. THE CUSTOMER WAS ABLE TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. ON DEVICE TO BE RETURNED FOR ANALYSIS BY THE CUSTOMER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MTOME ST HOLSTER/CABLES		KNW	ETHICON ENDO SURGERY, INC (CINCINNATI)	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1				CONTROL MODULE AND PROBE