FDA Adverse Event
Injury
Summary report: N
UNKNOWN DUET SULU
MDR report key: 2644889
·
Received June 28, 2012
Report
- Report Number
- 1219930-2012-00563
- Event Type
- Injury
- Date Received
- June 28, 2012
- Report Date
- June 21, 2012
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- GDW
- PMA / PMN Number
- K080898
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: BETWEEN (B)(6) 2008 AND (B)(6) 2011, WE RETROSPECTIVELY REVIEWED THE MEDICAL RECORDS OF 116 CONSECUTIVE PTS THAT UNDERWENT LSG WITH STAPLE LINE BUTTRESS REINFORCEMENT AT AN (B)(6) HOSPITAL WITH ADVANCED BARIATRIC FELLOWSHIP. THERE WERE 116 CONSECUTIVE PTS THAT UNDERWENT LSG WITH THE DUET TRS AS PART OF A COMPREHENSIVE WEIGHT MANAGEMENT STRATEGY THROUGH THE WEIGHT WISE PROGRAM INCLUDED IN THE ANALYSIS. THE REPORTERS OBSERVED ONE CASE OF BLEEDING FROM THE GASTRIC STAPLE LINE, WHICH REQUIRED REOPERATION WITH LOCAL LAPAROSCOPIC OVER SEWING WITH CONTINUOUS SUTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DUET SULU | NONE | GDW | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |