FDA Adverse Event
Malfunction
Summary report: N
PROGRASP (TM) FORCEPS INSTRUMENT
MDR report key: 2942421
·
Received February 4, 2013
Report
- Report Number
- 2955842-2013-00344
- Event Type
- Malfunction
- Date Received
- February 4, 2013
- Date of Event
- December 4, 2012
- Report Date
- January 8, 2013
- Manufacturer
- INTUITIVE SURGICAL,INC.
- Product Code
- NAY
- PMA / PMN Number
- K050369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS FOUND TO BE BROKEN AT THE PROXIMAL CLEVIS TO THE MAIN TUBE INTERFACE. THE MAIN TUBE WAS CRACKED AT THE INTERFACE. THE CLEVIS WAS FOUND TO BE DISLODGED FROM THE MAIN TUBE AS A RESULT. NO MISSING PIECES. THE BREAKAGE WAS LIKELY DUE TO OVERLOADING AT THE TIP. 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 CLEANING AND STERILIZATION, THE CUSTOMER NOTED A BROKEN HINGE ON THE PROGRASP FORCEPS INSTRUMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46531 | PROGRASP (TM) FORCEPS INSTRUMENT | ENDOSCOPIC INSTRUMENT | NAY | INTUITIVE SURGICAL,INC. | 420093-08 | M10121030 722 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES |