FDA Adverse Event
Malfunction
Summary report: N
PK DISSECTING FORCEPS INSTRUMENT
MDR report key: 2972286
·
Received February 21, 2013
Report
- Report Number
- 2955842-2013-00585
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- January 17, 2013
- Report Date
- January 22, 2013
- Manufacturer
- INTUITIVE SURGICAL,INC.
- Product Code
- NAY
- PMA / PMN Number
- K061260
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE PITCH UP CABLE WAS FOUND TO BE BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A DAVINCI S TONGUE BASE RESECTION PROCEDURE, THE CUSTOMER NOTED A BROKEN WIRES ON THE PK DISSECTING FORCEPS INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75568 | PK DISSECTING FORCEPS INSTRUMENT | ENDOSCOPIC ELECTROSURGICAL INSTRUMENT | NAY | INTUITIVE SURGICAL,INC. | 420227-03 | M10121006 526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | DAVINCI S SYSTEM, ESU, INSTRUMENTS & ACCESSORIES |