FDA Adverse Event
Injury
Summary report: N
MAX GR 1X27 T16 3/0
MDR report key: 2202374
·
Received August 3, 2011
Report
- Report Number
- 1219930-2011-00616
- Event Type
- Injury
- Date Received
- August 3, 2011
- Date of Event
- June 30, 2011
- Report Date
- July 6, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GAM
- PMA / PMN Number
- K099051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAPAROSCOPIC RADICAL PROSTATECTOMY. ACCORDING TO THE REPORTER: DURING ANASTOMOSING BLADDER AND URETHRA, THE SURGEON FOUND THE NEEDLE DETACHED FROM THE SUTURE. IT WAS THE 4TH STITCH OF A CONTINUOUS SUTURE. THE NEEDLE WENT DEEP INTO THE CAVITY AND THE SURGEON SPENT A LONG TIME TO FIND IT. BECAUSE OF DAMAGE TO THE RECTUM, THE PROCEDURE CHANGED TO LAPAROTOMY AND RESULTED IN AN ARTIFICIAL ANUS. THE NEEDLE WAS REMOVED FROM THE CAVITY. OPERATIVE TIME WAS EXTENDED MOR THAN 30 MINUTES. THIS MATTER CAUSED TISSUE DAMAGE AND OOZING UNDER 200CC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAX GR 1X27 T16 3/0 | ABSORBABLE SYNTHETIC SUTURE | GAM | UNITED STATES SURGICAL | A0C1090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |