FDA Adverse Event
Malfunction
Summary report: N
ENDO STITCH*POLYSORB* 2/0 48 VIO DLU SU
MDR report key: 4200521
·
Received October 24, 2014
Report
- Report Number
- 1219930-2014-00977
- Event Type
- Malfunction
- Date Received
- October 24, 2014
- Report Date
- October 21, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL A DIVISON
- Product Code
- KOG
- PMA / PMN Number
- K934738
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: GASTROINTESTINAL. ACCORDING TO THE REPORTER: THE CUSTOMER STATES THE SUTURE DETACHED FROM THE NEEDLE IN TWO DIFFERENT CASES WHEN THE USER WAS PERFORMING A GASTRIC ANASTOMOSIS. (B)(4) FOR SECOND CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678854 | ENDO STITCH*POLYSORB* 2/0 48 VIO DLU SU | SINGLE USE SUTURING DEVICE | KOG | COVIDIEN, FORMERLY US SURGICAL A DIVISON | 170053 | B3L0484X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |