FDA Adverse Event
Injury
Summary report: N
EGIA ULTRA UNIVERSAL SHORT STAPLER
MDR report key: 3894038
·
Received June 18, 2014
Report
- Report Number
- 2647580-2014-00446
- Event Type
- Injury
- Date Received
- June 18, 2014
- Date of Event
- May 22, 2014
- Report Date
- May 27, 2014
- Manufacturer
- COVIDIEN, FORMERLY USSC
- Product Code
- GDW
- PMA / PMN Number
- K083519
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: VATS LOBECTOMY. ACCORDING TO THE REPORTER: AFTER THREE FIRING THIRD SULU WAS JAMMED AFTER FIRING. HANDLE WAS CHANGED AND SAME HAPPENED AFTER SECOND FIRING. PERISTRIP WAS USED WITH ALL OF THESE SULUS. PATIENT NEEDED THORACOTOMY TO RELEASE SULU FROM TISSUE. THERE WAS EXTENSION OF SURGERY TIME.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: PER ADDITIONAL INFORMATION RECEIVED, THERE WAS UNANTICIPATED TISSUE LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 358921 | EGIA ULTRA UNIVERSAL SHORT STAPLER | DISPOSABLE SURGICAL STAPLER | GDW | COVIDIEN, FORMERLY USSC | P3K0112X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S | EGIA 45 ARTICULATING MED/THICK SULU, EGIA45AMT,| PRODUCT LOT #: N4A0550KX, EXP DATE 01/31/2019,| MFG DATE 01/2014 |