FDA Adverse Event
Malfunction
Summary report: N
ENDO STITCH 10MM SUTURING DEVICE
MDR report key: 2514157
·
Received March 23, 2012
Report
- Report Number
- 2647580-2012-00198
- Event Type
- Malfunction
- Date Received
- March 23, 2012
- Date of Event
- February 27, 2012
- Report Date
- February 27, 2012
- Manufacturer
- USSC PUERTO RICO
- Product Code
- MFJ
- PMA / PMN Number
- K934738
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: HYSTERECTOMY. ACCORDING TO THE REPORTER, THE V-LOC NEEDLE/SUTURE DETACHED FROM THE JAWS OF THE ENDOSTITCH WHILE BEING PASSED THROUGH THE TISSUE. ANOTHER RELOAD AND ENDOSTITCH WERE USED. THE NEEDLE WAS CUT LOOSE. A NEW RELOAD WAS USED TO COMPLETE THE CLOSURE. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 250CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. NOTHING FELL INTO THE CAVITY. THERE WAS NO TISSUE DAMAGE OR UNANTICIPATED TISSUE LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO STITCH 10MM SUTURING DEVICE | DISPOSABLE SUTURING DEVICE | MFJ | USSC PUERTO RICO | N1K0559X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LOT #V1G0004| VLOC 180 ESTCH ABS 2-0 6 LP: (B)(4), |