FDA Adverse Event Malfunction Summary report: N

MARYLAND BIPOLAR FORCEPS INSTRUMENT

MDR report key: 3896705 · Received June 26, 2014

Report

Report Number: 2955842-2014-03938
Event Type: Malfunction
Date Received: June 26, 2014
Date of Event: June 18, 2014
Report Date: June 24, 2014
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K050369
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED COMPLAINT OF WHEN THE INSTRUMENT IS PLUGGED IN, IT SHORTS OUT. VISUAL INSPECTION WAS CONDUCTED AND NO TROUBLE WAS FOUND. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE DA VINCI SYSTEM AND A WET PAPER TOWEL WAS HELD IN BETWEEN THE GRIP AND ENERGY PEDAL WAS PRESSED. THE GRIP PASSED ENERGY AND SMOKE CAME OUT, INDICATING ENERGY WAS ABLE TO PASS THROUGH PROPERLY. THIS TEST WAS CONDUCTED FOR A PERIOD OF ABOUT 2-3 MINUTES LONG. NO TROUBLE WAS FOUND DURING TESTING. FAILURE ANALYSIS FOUND THE INSTRUMENT'S MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF THE MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES MEASURED APPROXIMATELY 0.266 - 0.165 IN LENGTH AND WAS NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND.

Description of Event or Problem · 1

IT WAS REPORTED THAT IN CENTRAL PROCESSING, WHEN THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS PLUGGED IN, IT WAS OBSERVED THAT IT SHORTS OUT. IT DID NOT WORK. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
373286	MARYLAND BIPOLAR FORCEPS INSTRUMENT	ENDOSCOPIC ELECTROSURGICAL INSTRUMENT	NAY	INTUITIVE SURGICAL,INC.	420172-07	N10140120 079

Patients

Seq	Age	Sex	Outcome	Treatment
1