FDA Adverse Event
Injury
Summary report: N
ENDO STITCH POLYSORB 0 48 VIO DLU SU
MDR report key: 2944048
·
Received January 24, 2013
Report
- Report Number
- 1219930-2013-00037
- Event Type
- Injury
- Date Received
- January 24, 2013
- Date of Event
- April 19, 2012
- Report Date
- January 3, 2013
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL
- Product Code
- OCW
- PMA / PMN Number
- K934738
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: GYNECOLOGY. ACCORDING TO THE REPORTER: THE POLYSORB SUTURE NEEDLE STUCK IN VAGINAL CUFF WHEN SURGEON WAS SUTURING IN VAGINAL CUFF. SURGEON SAID THE TIP OF ENDOSTITCH APPROX A 0.5 CM TITANIUM TIP, WAS ENCAPSULATED INTO THE VAGINAL CUFF AS IT SNAPPED OFF THE SUTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 34670 | ENDO STITCH POLYSORB 0 48 VIO DLU SU | SURGICAL SUTURING DEVICE | OCW | COVIDIEN, FORMERLY US SURGICAL | N2A0780YX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |