FDA Adverse Event
Malfunction
Summary report: N
MAESTRO STRAIGHT M ATTACHMENT
MDR report key: 1873643
·
Received September 17, 2010
Report
- Report Number
- 1811755-2010-01190
- Event Type
- Malfunction
- Date Received
- September 17, 2010
- Date of Event
- September 3, 2010
- Report Date
- September 3, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE, IF THE INVESTIGATION DETAILS REQUIRE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE OVERHEATED DURING IN-HOUSE TESTING. THERE WAS NO PT INVOLVEMENT AND NO REPORT OF ADVERSE CONSEQUENCES IN THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAESTRO STRAIGHT M ATTACHMENT | EAR, NOSE, AND THROAT ELECTRIC OR PNEUMATIC SURGIC | ERL | STRYKER INSTRUMENTS KALAMAZOO | 1014708333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |