FDA Adverse Event
Injury
Summary report: N
EGIA ULTRA UNIVERSAL STAPLER
MDR report key: 4190242
·
Received October 21, 2014
Report
- Report Number
- 2647580-2014-00900
- Event Type
- Injury
- Date Received
- October 21, 2014
- Date of Event
- October 6, 2014
- Report Date
- October 6, 2014
- Manufacturer
- COVIDIEN, FORMERLY USSC PUERTO RICO INC
- Product Code
- GDW
- PMA / PMN Number
- K083519
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: NEPHRECTOMY. ACCORDING TO THE REPORTER: AS THE SURGEON WAS TAKING THE RENAL VEIN WITH THE STAPLER, MIDWAY THROUGH THE FIRE, IT MADE A LOUD POP AND PIECES OF THE RELOAD DISENGAGED FROM THE STAPLER. THE STAPLER LOCKED UP ON THE PATIENT'S TISSUE AND THE SURGEON WAS UNABLE TO OPEN THE JAWS OF THE STAPLER. THEY USED MONOPOLAR ENERGY TO REMOVE THE STAPLER FROM THE PATIENT. NO REINFORCEMENT MATERIAL WAS USED. THERE WAS UNANTICIPATED TISSUE DAMAGE DUE TO THE INSTRUMENT LOCKED ON TISSUE. PIECES OF THE DEVICE FELL INTO THE PATIENT'S CAVITY AND THE SURGEON BELIEVES THEY REMOVED ALL THE PIECES BUT THEY ARE NOT SURE. THERE WAS NO BLOOD LOSS OR EXTENSION OVER 30MIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 668505 | EGIA ULTRA UNIVERSAL STAPLER | DISPOSABLE SURGICAL STAPLER | GDW | COVIDIEN, FORMERLY USSC PUERTO RICO INC | EGIAUSTND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R| S | EGIAUSTND, EGIA ULTRA UNIVERSAL STAPLER |