FDA Adverse Event
Malfunction
Summary report: N
CODMAN MODULAR AIR DRIVER
MDR report key: 2889124
·
Received December 28, 2012
Report
- Report Number
- 1226348-2012-84134
- Event Type
- Malfunction
- Date Received
- December 28, 2012
- Date of Event
- November 7, 2012
- Manufacturer
- J&J PROF, INC
- Product Code
- KFK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE VENDOR'S EVALUATION REVEALED THAT INSTRUMENTS WERE CORRODED, MISSING COMPONENTS, AND WORN. THE CONDITION OF THESE INSTRUMENTS IS ASSOCIATED WITH EXCESSIVE USE OVER A LONG PERIOD OF TIME. INSTRUMENTS ARE OLD AND ARE OUT OF WARRANTY. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.
Additional Manufacturer Narrative · 1
UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.
Description of Event or Problem · 1
THE AFFILIATE REPORTED THAT THE SECURE DO NOT ALLOW THE ACTIVATION OF THE EQUIPMENT AND THE TREPHONE PIECE GOT STUCK. AFFILIATE REPORTED DALAY IN SURGERY AS A RESULT OF THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODMAN MODULAR AIR DRIVER | CRANIOTOME DRIVER | KFK | J&J PROF, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4) |