FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 3
MDR report key: 1162302
·
Received September 8, 2008
Report
- Report Number
- 3005075853-2008-01562
- Event Type
- Malfunction
- Date Received
- September 8, 2008
- Date of Event
- August 14, 2008
- Report Date
- August 15, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4, H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, AFTER THE SURGEON FIRED THE DEVICE, HE FOUND SOME STAPLES WERE MALFORMED. THEN HE USED HAND SEWING TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 3 | GDW | ETHICON ENDO-SURGERY, LLC. | NA | D4J23M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |