FDA Adverse Event
Malfunction
Summary report: N
DOUBLE-ENDED, EXTRACTOR-LARGE HOOK
MDR report key: 4231126
·
Received March 31, 2010
Report
- Report Number
- 2953189-2010-00028
- Event Type
- Malfunction
- Date Received
- March 31, 2010
- Date of Event
- March 30, 2010
- Report Date
- March 30, 2010
- Manufacturer
- COVIDIEN
- Product Code
- GDG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 03/30/2010. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A PHLEBECTOMY INSTRUMENT. THE CUSTOMER REPORTS THAT THE ENTIRE HOOKED AREA BROKE OFF IN THE PT. CUSTOMER REPOTS THAT THE PHYSICIAN MADE A LITTLE LARGER INCISION TO FIND THE DETACHED COMPONENT. PHYSICIAN REMOVED TO PIECE WITH HEMOSTATS. NO ILL EFFECTS TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DOUBLE-ENDED, EXTRACTOR-LARGE HOOK | PHLEBECTOMY INSTRUMENT | GDG | COVIDIEN | VPH-VA3 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |