FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE SABER DRILL
MDR report key: 1813026
·
Received August 12, 2010
Report
- Report Number
- 1811755-2010-00931
- Event Type
- Malfunction
- Date Received
- August 12, 2010
- Date of Event
- July 23, 2010
- Report Date
- July 23, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND AN INVESTIGATION IS ANTICIPATED. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE INVESTIGATION RESULTS REQUIRE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A MASTOIDECTOMY, THE HANDPIECE HEATED UP. THE PROCEDURE WAS COMPLETED USING BACKUP EQUIPMENT, WITHOUT CAUSING A CLINICALLY SIGNIFICANT DELAY. NO PATIENT OR USER INJURIES WERE REPORTED, AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR CORE SABER DRILL | DRILLS, SURGICAL, ENT (ELECTRIC OR PNEUMATIC), INC | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |