FDA Adverse Event
Injury
Summary report: N
UNK VLOC PRODUCT
MDR report key: 3231877
·
Received July 10, 2013
Report
- Report Number
- 1219930-2013-00527
- Event Type
- Injury
- Date Received
- July 10, 2013
- Report Date
- June 17, 2013
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- GAT
- PMA / PMN Number
- K103052
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
TRACKING NUMBER: (B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: MYOMECTOMY. ACCORDING TO THE REPORTER: AN ABDOMINAL X-RAY FOLLOWED BY CT SCAN DEMONSTRATED DILATED LOOPS OF ILEUM WITH AIR FLUID LEVELS AND A TRANSITION POINT WITH COLLAPSED TERMINAL ILEUM DISTALLY. AT LAPAROSCOPY IT BECAME EVIDENT THAT A SEGMENT OF SMALL BOWEL WAS WRAPPED AROUND A 4CM LENGTH OF UNRAVELED V-LOC SUTURE PROTRUDING FROM THE MYOMECTOMY SITE. THE BOWEL WAS FREED EASILY LAPAROSCOPICALLY, SUSTAINING NO TRAUMA AND THE VISIBLE V-LOC SUTURE REMOVED. THE UTERUS APPEARED NORMAL WITH NO ADHESIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 318541 | UNK VLOC PRODUCT | VLOC | GAT | COVIDIEN, FORMERLY US SURGICAL | NOT AVAILABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |