FDA Adverse Event
Malfunction
Summary report: N
T5 LT WT FIBER OPT SURG HELMET
MDR report key: 4873618
·
Received June 28, 2015
Report
- Report Number
- 0001811755-2015-02331
- Event Type
- Malfunction
- Date Received
- June 28, 2015
- Date of Event
- June 9, 2015
- Report Date
- June 10, 2015
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- FXZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS IS IN PROGRESS.
Additional Manufacturer Narrative · 1
THE DEVICE WAS SCRAPPED BY STRYKER.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE DEVICE OVERHEATED AND THE TIP OF THE FIBER OPTIC CABLE MELTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE OVERHEATED AND THE TIP OF THE FIBER OPTIC CABLE MELTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 417360 | T5 LT WT FIBER OPT SURG HELMET | HELMET, SURGICAL | FXZ | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |