FDA Adverse Event
Other
Summary report: N
VASCUCLEAR PRECISION BIPOLAR
MDR report key: 2913634
·
Received January 7, 2013
Report
- Report Number
- 1718850-2012-01122
- Event Type
- Other
- Date Received
- January 7, 2013
- Report Date
- December 11, 2012
- Manufacturer
- SORIN GROUP USA, INC.
- Product Code
- GEI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR DATE WILL BE PROVIDED WHEN THE LOT NUMBER IS REC¿D. SORIN GROUP REC¿D A REPORT THAT THE TIP OF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE BROKE OFF. SORIN GROUP HAS REQUESTED ADD¿L INFO REGARDING PT INVOLVEMENT AND STATUS. THIS INFO WILL BE PROVIDED WHEN IT IS REC¿D. THE INVESTIGATION IS ON-GOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
SORIN GROUP REC¿D A REPORT THAT THE TIP OF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE BROKE OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8909 | VASCUCLEAR PRECISION BIPOLAR | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | SORIN GROUP USA, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |