FDA Adverse Event
Injury
Summary report: N
ENDO DISSECT 5MM INSTRUMENT
MDR report key: 2150489
·
Received June 16, 2011
Report
- Report Number
- 2647580-2011-00425
- Event Type
- Injury
- Date Received
- June 16, 2011
- Date of Event
- June 3, 2011
- Report Date
- June 7, 2011
- Manufacturer
- USSC PUERTO RICO
- Product Code
- GET
- PMA / PMN Number
- K904578
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: APPENDECTOMY. ACCORDING TO THE REPORTER: AT THE TIME OF THE OPERATION, THE TIP OF THE DEVICE HAD BEEN BROKEN. THE SURGEON DECIDED TO CONTINUE WITH AN OPEN OPERATION AND THE WHOLE OPERATION TOOK 2.5 HOURS. ACCORDING TO THE REPORTER, UNDER NORMAL CONDITIONS, THE SURGERY WOULD USUALLY ONLY TAKE ABOUT 1 HOUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO DISSECT 5MM INSTRUMENT | SINGLE USE LAPAROSCOPIC HAND INSTRUMENT | GET | USSC PUERTO RICO | P0K0862 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |