FDA Adverse Event
Malfunction
Summary report: N
ENDO STITCH POLYSORB* 3/0 7 VIO DLU SU
MDR report key: 3823213
·
Received February 27, 2014
Report
- Report Number
- 1219930-2014-00142
- Event Type
- Malfunction
- Date Received
- February 27, 2014
- Date of Event
- January 30, 2014
- Report Date
- February 4, 2014
- Manufacturer
- COVIDIEN LP, FORMERLY US SURGICAL
- Product Code
- GCJ
- PMA / PMN Number
- K934738
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LAP GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE INSTRUMENT DIDN'T PRESENT ANY DIFFICULTIES. THE SUTURE FELL OFF THE NEEDLE ON THE 3 DIFFERENT RELOADS DURING THE PROCEDURE. THERE IS NO INFO ON IF THE NEEDLE FELL INTO THE CAVITY. THERE WAS NO INJURY TO THE PT. THE DEVICES THAT WERE USED IN THE CASE WERE DISPOSED OF AND SEALED SAMPLES ARE BEING RETURNED FOR INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122628 | ENDO STITCH POLYSORB* 3/0 7 VIO DLU SU | DISPOSABLE SUTURING DEVICE | GCJ | COVIDIEN LP, FORMERLY US SURGICAL | B3B0807X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |