FDA Adverse Event
Malfunction
Summary report: N
ENDO STITCH SURGIDAC 2/0 48 GRB DKY SY
MDR report key: 3908134
·
Received March 7, 2014
Report
- Report Number
- 9612501-2014-00051
- Event Type
- Malfunction
- Date Received
- March 7, 2014
- Date of Event
- February 6, 2014
- Report Date
- February 6, 2014
- Manufacturer
- COVIDIEN
- Product Code
- KOG
- PMA / PMN Number
- K934738
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: DR (B)(6) WAS DOING A RUNNING STITCH WITH THE ENDOSTITCH 2-0 SURGIDAC THROUGH THE MESENTERY WHEN HALFWAY THROUGH THE HIS RUN THE SURGIDAC BROKE. THERE WAS NO PATIENT INJURY. THERE WAS NO TISSUE DAMAGE, UNANTICIPATED BLOOD LOSS, UNANTICIPATED COLOSTOMY, FORMAL LAPAROTOMY, RE-OPERATION, CONVERSION TO OPEN PROCEDURE, OR EXTENDED OPERATING TIME. DR (B)(6) TIED THE BROKEN ENDS TOGETHER TO COMPLETE THE RUNNING SUTURE THROUGH THE MESENTERY. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 140379 | ENDO STITCH SURGIDAC 2/0 48 GRB DKY SY | DISPOSABLE SUTURING DEVICE | KOG | COVIDIEN | J3K1410X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |