FDA Adverse Event
Injury
Summary report: N
UNKNOWN VLOC PRODUCT
MDR report key: 3170114
·
Received June 6, 2013
Report
- Report Number
- 1219930-2013-00426
- Event Type
- Injury
- Date Received
- June 6, 2013
- Date of Event
- April 12, 2013
- Report Date
- May 13, 2013
- Manufacturer
- COVIDIEN, FORMERLY U.S. SURGICAL
- Product Code
- GAM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: POLYPECTOMY. ACCORDING TO THE REPORTER: V LOC NEEDLE BROKE WHILE SUTURING RETAINED, UNABLE TO RETRIEVE. SURGEON HAD DIFFICULTY TOGGLING THE DEVICE, HEARD A CRACK AND THE NEEDLE WAS NOT ENGAGED AND BROKEN. X-RAY WAS PERFORMED AND NOTED THE BROKEN NEEDLE TIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252044 | UNKNOWN VLOC PRODUCT | VLOC SUTURE | GAM | COVIDIEN, FORMERLY U.S. SURGICAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |