FDA Adverse Event
Malfunction
Summary report: N
MEGASUTURECUT NEEDLE DRIVER INSTRUMENT
MDR report key: 2872029
·
Received December 11, 2012
Report
- Report Number
- 2955842-2012-01239
- Event Type
- Malfunction
- Date Received
- December 11, 2012
- Date of Event
- October 18, 2012
- Report Date
- November 12, 2012
- Manufacturer
- INTUITIVE SURGICAL, INC.
- Product Code
- NAY
- PMA / PMN Number
- K050369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ONE GRIP CABLE IS BROKEN AT THE DISTAL IDLERS. THE CABLE SEGMENT STICKS OUT AT WRIST. THE IDLER PULLEY SPINS FREELY AND WAS NOT DAMAGED. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE CABLE ON THE MEGASUTURECUT NEEDLE DRIVER INSTRUMENT BROKE. THERE WAS NO MISSING OR FALLEN PIECES REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEGASUTURECUT NEEDLE DRIVER INSTRUMENT | ENDOSCOPIC INSTRUMENT, NAY | NAY | INTUITIVE SURGICAL, INC. | 420309-01 | M10120601 071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ACCESSORIES| DA VINCI SI SYSTEM |