FDA Adverse Event
Malfunction
Summary report: N
TPS HANDPIECE CORD
MDR report key: 3052848
·
Received April 11, 2013
Report
- Report Number
- 0001811755-2013-00758
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- March 15, 2013
- Report Date
- March 15, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
UPON DISASSEMBLY FOR VISUAL INSPECTION INTERNAL WIRE DAMAGE OF THE CABLE WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TPS HANDPIECE CORD CAUSED HANDPIECES TO UNINTENTIONALLY ACTIVATE DURING A ROUTINE EQUIPMENT EVALUATION AT THE USER FACILITY, BY A MANUFACTURER'S SERVICE TECHNICIAN. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TPS HANDPIECE CORD CAUSED HANDPIECES TO UNINTENTIONALLY ACTIVATE DURING A ROUTINE EQUIPMENT EVALUATION AT THE USER FACILITY, BY A MANUFACTURER'S SERVICE TECHNICIAN. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156721 | TPS HANDPIECE CORD | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | ERL | STRYKER INSTRUMENTS-KALAMAZOO | 07318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |