FDA Adverse Event
Malfunction
Summary report: N
HS LONG 5MM CURVED SHEARS
MDR report key: 1152763
·
Received September 10, 2008
Report
- Report Number
- 1527736-2008-03742
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- May 27, 2008
- Report Date
- May 30, 2008
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- GEI
- PMA / PMN Number
- K002981
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 06/16/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE WORKED FOR APPROX 45 MINUTES AND THEN STOPPED. IT WAS NOTICED AFTER THE CASE THE TIP WAS BROKEN OFF. IT IS UNK IF THE TIP FELL INTO THE PT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. PT CONSEQUENCE IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HS LONG 5MM CURVED SHEARS | GEI | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |