FDA Adverse Event
Injury
Summary report: N
EGI 30 CURVED TIP ARTICULATING VAS SULU
MDR report key: 3716140
·
Received March 25, 2014
Report
- Report Number
- 1219930-2014-00242
- Event Type
- Injury
- Date Received
- March 25, 2014
- Date of Event
- February 27, 2014
- Report Date
- March 5, 2014
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- GDW
- PMA / PMN Number
- K083519
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LOBECTOMY. ACCORDING TO THE REPORTER: THE FIRST FIRING ON LUNG VEIN WAS COMPLETED WITH NOTHING ABNORMAL RECOGNIZED IN USE OF THE INSTRUMENT. HOWEVER, THE CONTINUOUS BLEEDING OCCURRED FROM THE CUT EDGE OF VESSEL. WITH PERFORMING THE ASTRICTION TREATMENT, CONFIRMED THE INSTRUMENT COULD NOT CUT IT COMPLETELY TO THE DISTAL END. THE DOCTOR USED THE SURGICAL SCISSORS FOR THE COMPLETE RESECTION TO THE END. HOWEVER THE BLEEDING WOULD NOT STOP AND FURTHER ASTRICTION TREATMENT WAS GIVEN. ALSO REPORTED THE DOCTOR CONFIRMED THE FAILURE OF STAPLING IN SOME PART. OPERATING TIME EXTENDED: MORE THAN 30 MINUTES. ADD'L TISSUE RESECTION: YES. TISSUE DAMAGE: YES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176586 | EGI 30 CURVED TIP ARTICULATING VAS SULU | DISPOSABLE SURGICAL STAPLER | GDW | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | N3M0737GX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability |