FDA Adverse Event
Malfunction
Summary report: N
ENDO STITCH 10MM SUTURING DEVICE
MDR report key: 2760381
·
Received September 18, 2012
Report
- Report Number
- 1219930-2012-00778
- Event Type
- Malfunction
- Date Received
- September 18, 2012
- Date of Event
- September 3, 2012
- Report Date
- September 7, 2012
- Manufacturer
- COVIDIEN, FORMERLY US
- Product Code
- KOG
- PMA / PMN Number
- K934738
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: NISSEN. ACCORDING TO THE REPORTER: THERE WAS DIFFICULTY TOGGLING THE NEEDLE BACK AND FORTH. EVENTUALLY THE NEEDLE BROKE INSIDE THE PT'S CAVITY BUT THE SURGEON WAS ABLE TO REMOVE IT COMPLETELY. THERE WAS NO TISSUE DAMAGE, UNANTICIPATED BLOOD LOSS, UNANTICIPATED COLOSTOMY, FORMAL LAPAROTOMY, RE-OPERATION, CONVERSION TO OPEN PROCEDURE, OR EXTENDED OPERATING ROOM TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO STITCH 10MM SUTURING DEVICE | DISPOSABLE SUTURING DEVICE | KOG | COVIDIEN, FORMERLY US | N2G0367X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |