FDA Adverse Event
Malfunction
Summary report: N
COAG SHEARS, 1UP 15MM SCIS GRP
MDR report key: 1190768
·
Received October 7, 2008
Report
- Report Number
- 3005075853-2008-02146
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 11, 2008
- Report Date
- September 12, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GEI
- PMA / PMN Number
- K002981
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TISSUE PAD WAS MELTED DURING USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COAG SHEARS, 1UP 15MM SCIS GRP | GEI | ETHICON ENDO-SURGERY, LLC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |