FDA Adverse Event
Malfunction
Summary report: N
PERMANENT CAUTERY HOOK INSTRUMENT
MDR report key: 2851837
·
Received November 29, 2012
Report
- Report Number
- 2955842-2012-01106
- Event Type
- Malfunction
- Date Received
- November 29, 2012
- Date of Event
- June 15, 2012
- Report Date
- June 15, 2012
- Manufacturer
- INTUITIVE SURGICAL,INC.
- Product Code
- NAY
- PMA / PMN Number
- K050369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 THE PERMANENT CAUTERY HOOK INSTRUMENT HAD A BROKEN WIRE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERMANENT CAUTERY HOOK INSTRUMENT | ENDOSCOPIC ELECTROSURGICAL INSTRUMENT | NAY | INTUITIVE SURGICAL,INC. | 420183-06 | M10111122 839 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES |