FDA Adverse Event
Other
Summary report: N
ELECTROCAUTERY PROBE, 34 CM
MDR report key: 3070198
·
Received April 16, 2013
Report
- Report Number
- 1223422-2013-00015
- Event Type
- Other
- Date Received
- April 16, 2013
- Report Date
- April 17, 2013
- Manufacturer
- MICROLINE SURGICAL, IN
- Product Code
- GEI
- PMA / PMN Number
- K981188
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE (B)(4) ELECTROCAUTERY PROBE WAS NOT RETURNED IN A TIMELY MANNER, THEREFORE NO INVESTIGATION COULD BE CONDUCTED.
Description of Event or Problem · 1
THE TIP FELL FROM THE HANDLE DURING A PROCEDURE. THE SURGEON WAS PULLING A VESSEL WITH THE TIP, WHEN THE TIP BROKE AND FELL INSIDE THE PATIENT. THE PATIENT WAS NOT HARMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 164264 | ELECTROCAUTERY PROBE, 34 CM | PROBE, 34C | GEI | MICROLINE SURGICAL, IN | 6924 | 00108547 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |