FDA Adverse Event
Malfunction
Summary report: N
ETS - ENDOSCOPIC LINEAR CUTTER (VASCULAR/THIN) - 35 MM
MDR report key: 1831748
·
Received January 15, 2008
Report
- Report Number
- 1527736-2008-00271
- Event Type
- Malfunction
- Date Received
- January 15, 2008
- Date of Event
- January 2, 2008
- Report Date
- January 7, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE STAPLES AT THE DISTAL END FORMED BUT NOT AT THE PROXIMAL END AND THE KNIFE BLADE DID NOT ADVANCE OR CUT. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETS - ENDOSCOPIC LINEAR CUTTER (VASCULAR/THIN) - 35 MM | GDW | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | D4J60A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |