FDA Adverse Event
Injury
Summary report: N
DST SERIES EEA ORVIL 25MM DEVICE
MDR report key: 2202430
·
Received August 5, 2011
Report
- Report Number
- 2647580-2011-00518
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- July 17, 2011
- Report Date
- July 27, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: DURING THE OPERATION, WHEN THE DEVICE WAS CONNECTED TO THE EEAXL25, THE NAIL DRILL PIPE (THREE PIECES OF BAYONET SOCKET) CRACKED IRREGULARLY ON THE OUTSIDE, THUS IT WAS IMPOSSIBLE TO JOIN SUCCESSFULLY, THEREFORE, THE SURGEON COULD NOT TRIGGER THE INSTRUMENT. BLOOD LOSS GREATER THAN 250CC OCCURRED. THE INCISION HAD TO BE EXTENDED. UNANTICIPATED TISSUE LOSS OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DST SERIES EEA ORVIL 25MM DEVICE | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | UNITED STATES SURGICAL | N0H0003UL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | MANUF: 07/2010, EXP: 07/31/2015| EEA XL 25MM SINGLE-USE STAPLER: CATALOG#: EEAXL25| LOT: P0G0613H, K062850 |