FDA Adverse Event
Malfunction
Summary report: N
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
MDR report key: 2895388
·
Received January 3, 2013
Report
- Report Number
- 2955842-2013-00027
- Event Type
- Malfunction
- Date Received
- January 3, 2013
- Date of Event
- December 3, 2012
- Report Date
- December 5, 2012
- Manufacturer
- INTUITIVE SURGICAL,INC.
- Product Code
- NAY
- PMA / PMN Number
- K050369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE PITCH CABLE IS BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP IS STILL INSTALLED IN THE CLEVIS. THE CLEVIS DOES NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. THE INSTRUMENT ALSO PASSED ELECTRICAL CONTINUITY TESTING. 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 PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CABLES ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WERE BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1957 | FENESTRATED BIPOLAR FORCEPS INSTRUMENT | ENDOSCOPIC ELECTROSURGICAL INSTRUMENT | NAY | INTUITIVE SURGICAL,INC. | 420205-05 | M10120404 174 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | DA VINCI SI SURG SYSTEM, ACCESSORIES AND ESU. |