FDA Adverse Event
Malfunction
Summary report: N
EPD 60000 RPM
MDR report key: 3140788
·
Received May 31, 2013
Report
- Report Number
- 8030965-2013-02579
- Event Type
- Malfunction
- Date Received
- May 31, 2013
- Date of Event
- June 1, 2011
- Report Date
- May 8, 2013
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWE
- PMA / PMN Number
- K043310
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CLASSIFICATION CODES DZI, ERL, HBE. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A CRANIOTOMY PROCEDURE ON (B)(6) 2011, THE ELECTRIC PEN DRIVE DEVICE STOPPED WORKING. THIS RESULTED IN THE CRANIOTOMY BEING UNABLE TO BE PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241683 | EPD 60000 RPM | HWE | SYNTHES GMBH | 2781 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |