FDA Adverse Event Malfunction Summary report: N

FENESTRATED BIPOLAR FORCEPS INSTRUMENT

MDR report key: 2980812 · Received February 27, 2013

Report

Report Number: 2955842-2013-00646
Event Type: Malfunction
Date Received: February 27, 2013
Date of Event: January 14, 2013
Report Date: January 29, 2013
Manufacturer: INTUITIVE SURGICAL,INC.
Product Code: NAY
PMA / PMN Number: K012833
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING EVALUATION FOUND THAT THE CLAMP DID NOT CLOSE. THE ONE GRIP WAS BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE WAS A .035 OFFSET AT THE TIPS. THE BENT GRIP HAD SEPARATION OF THE YAW PULLEY AND PULLEY COVER AT THE GLUE JOINT, INDICATING OVERLOADING AT THE TIP. THE SAME GRIP WAS ALSO TWISTED SO THAT ONE SIDE OF GRIPS HAD A .050 GAP WHEN GRIPS WERE IN THE CLOSED POSITION. THE GRASPING FUNCTIONALITY WAS DIMINISHED DUE TO THE GRIP DAMAGE. ADDITIONAL OBSERVATION WAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL AT THE DISTAL END OF THE MAIN TUBE. THE SCRATCHES WERE .060 - .200 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT DID NOT CLOSE. NO MISSING OR FALLEN PIECES WERE REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
84030	FENESTRATED BIPOLAR FORCEPS INSTRUMENT	ENDOSCOPIC ELECTROSURGICAL INSTRUMENT	NAY	INTUITIVE SURGICAL,INC.	400205-04	M10120608 821

Patients

Seq	Age	Sex	Outcome	Treatment
1				DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES