FDA Adverse Event
Summary report: N
CLEARGLIDE PRECISION BIPOLAR DEVICE
MDR report key: 1110046
·
Received August 7, 2008
Report
- Report Number
- 2248146-2007-00193
- Date Received
- August 7, 2008
- Date of Event
- October 7, 2007
- Report Date
- August 7, 2008
- Manufacturer
- DATASCOPE CORP.
- Product Code
- GEI
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THANK YOU FOR ADVISING US OF THIS REPORT. WE WILL CONTINUE TO MONITOR FOR THIS ISSUE.
Description of Event or Problem · 1
THE PLASTIC PIECE FROM THE JAWS ON THE BIPOLAR DEVICE BROKE. IN 2007, DATASCOPE WAS NOTIFIED THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLEARGLIDE PRECISION BIPOLAR DEVICE | ELECTROSURGICAL CUTTING & COAGULATION DEVICE | GEI | DATASCOPE CORP. | 0684-45-0001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |