FDA Adverse Event
Injury
Summary report: N
ENDO STITCH SURGIDAC 2/0 48 GRN DLU SU
MDR report key: 2042063
·
Received March 29, 2011
Report
- Report Number
- 1219930-2011-00247
- Event Type
- Injury
- Date Received
- March 29, 2011
- Report Date
- February 28, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- KOG
- PMA / PMN Number
- K934738
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: ROUX-EN-Y. ACCORDING TO THE REPORTER: THE SURGEON USED THE DEVICE TO CLOSE THE TRANSVERSE MESOCOLON AREA. SHE HAS HAD 4 PATIENTS THAT HAVE EXPERIENCED FAT NECROSIS AND CALCIFICATION CAUSING STENOSIS IN THE AREA OF THE SUTURE (TRANSVERSE MESOCOLON). IN A COUPLE OF THE CASES, SHE HAS HAD TO RE-OPERATE TO REMOVE THE CALCIFICATION AND OPEN THE AREA UP. THIS SEEMS TO OCCUR 6-12 MONTHS POST-OPERATIVELY WITH THE CALCIFICATION OF TISSUE. PATIENT STATUS: FINE AFTER RE-OPERATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO STITCH SURGIDAC 2/0 48 GRN DLU SU | DISPOSABLE SUTURING DEVICE SULU | KOG | UNITED STATES SURGICAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |