FDA Adverse Event
Malfunction
Summary report: N
INTERPULSE HANDPIECE WITH HIGH FLOW TIP
MDR report key: 2223270
·
Received August 16, 2011
Report
- Report Number
- 2648666-2011-00200
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- July 27, 2011
- Report Date
- July 28, 2011
- Manufacturer
- STRYKER INSTRUMENTS PUERTO RICO
- Product Code
- FQH
- PMA / PMN Number
- K972069
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BATTERY PACK BEGAN TO SMOKE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED USING THIS DEVICE WITH NO ALLEGATION OF ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERPULSE HANDPIECE WITH HIGH FLOW TIP | FQH | STRYKER INSTRUMENTS PUERTO RICO | 11143012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |