FDA Adverse Event
Other
Summary report: N
ENDO ANCHOR ENDOSCOPIC PROCEDURE ENDO ANCHOR
MDR report key: 413231
·
Received August 26, 2002
Report
- Report Number
- 1527736-2002-01785
- Event Type
- Other
- Date Received
- August 26, 2002
- Date of Event
- July 18, 2002
- Report Date
- July 30, 2002
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (INDEPENDENCIA PLANT)
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED WHEN THE DEVICE WAS USED DURING A HERNIA PROCEDURE, THE SURGEON SUSTAINED A HAND STICK. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO ANCHOR ENDOSCOPIC PROCEDURE ENDO ANCHOR | ENDO ANCHOR / OPEN ANCHOR FIXATION DEVICE | GCJ | ETHICON ENDO-SURGERY, INC. (INDEPENDENCIA PLANT) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |