FDA Adverse Event
Injury
Summary report: N
EGIA 45 ARTICULATING MED/THICK SULU
MDR report key: 3854902
·
Received May 28, 2014
Report
- Report Number
- 1219930-2014-00408
- Event Type
- Injury
- Date Received
- May 28, 2014
- Date of Event
- May 7, 2014
- Report Date
- May 8, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- GDW
- PMA / PMN Number
- K083519
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LOBECTOMY. NO PROBLEM TO COMPLETE THE SECOND FIRING. AFTER THE THIRD FIRING WAS DONE NORMALLY, WHEN THE BLACK RETURN KNOB WAS PULLED BACK IT STOPPED IN THE MIDDLE AND GOT STUCK. CONFIRMED NO PROBLEM IN JAW PRIOR TO USE. FOR RECOVERY THE TISSUE WAS CUT BY USE OF SURGICAL SCISSORS AND ALSO BY LIGATION OF THE ELECTRICAL PENCIL OR LIGATION WERE APPLIED TO STOP THE BLEEDING (UNDER 200 CC BLEEDING). NEW ONE WAS OPENED FOR EACH OF SULU AND DEVICE TO COMPLETE THE CASE WITH NO PROBLEM. ADDITIONAL TISSUE RESECTION AND TISSUE DAMAGE WERE REPORTED. IT IS UNKNOWN WHETHER REINFORCEMENT MATERIAL WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 315100 | EGIA 45 ARTICULATING MED/THICK SULU | DISPOSABLE SURGICAL STAPLER | GDW | COVIDIEN, FORMERLY US SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | 030403, GIA AUTO SUTURE UNIVERSAL STAPLER| K900129 |