FDA Adverse Event
Injury
Summary report: N
ENDO STITCH 10MM SUTURING DEVICE
MDR report key: 3170070
·
Received June 4, 2013
Report
- Report Number
- 1219930-2013-00421
- Event Type
- Injury
- Date Received
- June 4, 2013
- Date of Event
- April 10, 2013
- Report Date
- May 6, 2013
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- KOG
- PMA / PMN Number
- K934738
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: HYSTERECTOMY. ACCORDING TO THE REPORTER: SMALL NEEDLE FRAGMENT RETAINED AFTER BREAKING DURING PROCEDURE. X-RAY USED TO CONFIRM RETENTION IN THE VAGINAL CUFF AFTER RECOVERY EFFORTS UNSUCCESSFUL. PATIENT IS OK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 247478 | ENDO STITCH 10MM SUTURING DEVICE | SURGICAL SUTURING DEVICE | KOG | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | N3B0066X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |