FDA Adverse Event
Injury
Summary report: N
PROXIMATE HCS HEMORR CIR STAPL
MDR report key: 622322
·
Received July 22, 2005
Report
- Report Number
- 1527736-2005-03226
- Event Type
- Injury
- Date Received
- July 22, 2005
- Report Date
- June 28, 2005
- Manufacturer
- ETHICON ENDO-SURGERY, INC.(CINCINNATI)
- Product Code
- KDG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ODS PROCEDURE, CUTTING AND STAPLING WAS NOT COMPLETE; MALFORMED STAPLES, AND SOME OF THE STAPLES WERE STUCK HALFWAY IN THE DEVICE. OVERSTITCHED BY HAND TO COMPLETE THE PROCEDURE. EXPERIENCED POSTOPERATIVE BLEEDING AND HAD TO REOPERATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE HCS HEMORR CIR STAPL | PPH SET | KDG | ETHICON ENDO-SURGERY, INC.(CINCINNATI) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |