FDA Adverse Event
Malfunction
Summary report: N
ENDO STITCH 10MM SUTURING DEVICE
MDR report key: 3173505
·
Received June 12, 2013
Report
- Report Number
- 1219930-2013-00436
- Event Type
- Malfunction
- Date Received
- June 12, 2013
- Date of Event
- March 18, 2013
- Report Date
- May 21, 2013
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- KOG
- 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).
Description of Event or Problem · 1
PROCEDURE TYPE: ROUX-EN-Y. ACCORDING TO THE REPORTER: DEVICE WAS STICKING, NOT TOGGLING CORRECTLY. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500 CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NO DEVICE FRAGMENT OR COMPONENT FELL INTO THE PATIENTS CAVITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 266371 | ENDO STITCH 10MM SUTURING DEVICE | DISPOSABLE SUTURING DEVICE | KOG | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |