FDA Adverse Event
Injury
Summary report: N
ENDO GIA II 45-3.5 DLU
MDR report key: 2901674
·
Received January 2, 2013
Report
- Report Number
- 2647580-2012-00823
- Event Type
- Injury
- Date Received
- January 2, 2013
- Date of Event
- October 19, 2012
- Report Date
- December 4, 2012
- Manufacturer
- COVIDIEN, FORMERLY USSC
- Product Code
- GCJ
- PMA / PMN Number
- K061095
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE PT PRESENTED POSTOPERATIVE BLEEDING. NO MORE INFO AVAILABLE. NO PERMANENT DAMAGE. NO TEMPORARY DAMAGE. THE EVENT DID NOT PROLONG THE HOSPITAL STAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 688 | ENDO GIA II 45-3.5 DLU | DISPOSABLE SURGICAL STAPLING DEVICE | GCJ | COVIDIEN, FORMERLY USSC | P1K0565X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |