FDA Adverse Event
Malfunction
Summary report: N
MICRO RECIPROCATING SAW
MDR report key: 2771533
·
Received August 28, 2012
Report
- Report Number
- 1811755-2012-03677
- Event Type
- Malfunction
- Date Received
- August 28, 2012
- Date of Event
- August 30, 2012
- Report Date
- August 30, 2012
- Manufacturer
- STRYKER INSTRUMENTS, INSTRUMENTS DIV.
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP REPORT WILL BE FILED WHEN THE QUALITY INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT BROWN LIQUID WAS OBSERVED COMING FROM A HAND PIECE DURING THE STERILIZATION PROCESS. THE ACCOUNT WAS UNABLE TO PROVIDE DETAIL AS TO WHICH SPECIFIC HAND PIECE WAS LEAKING, AS THEY WERE ALL PLACED TOGETHER IN A REPAIR BIN. THERE WAS NO PT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO RECIPROCATING SAW | HBE | STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | MICRO RECIPROCATING SAW| MICRO SAGGITAL SAW: SN (B)(4) |