FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL HANDSWITCH
MDR report key: 4172235
·
Received October 15, 2014
Report
- Report Number
- 0001811755-2014-03609
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 17, 2014
- Report Date
- September 17, 2014
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- EIA
- PMA / PMN Number
- K032117
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FAILURE COULD NOT BE DUPLICATED AND NO COMPONENTS WERE IDENTIFIED WHICH WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE. THE DEVICE IS NOT A REPAIRABLE DEVICE AND WILL NOT BE RETURNED TO THE USER FACILITY.
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNIVERSAL HANDSWITCH WAS OPERATING WHEN IN SAFE MODE. UPON FOLLOW UP, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNIVERSAL HANDSWITCH WAS OPERATING WHEN IN SAFE MODE. UPON FOLLOW UP, THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654872 | UNIVERSAL HANDSWITCH | UNIT, OPERATIVE DENTAL | EIA | STRYKER INSTRUMENTS-KALAMAZOO | 13151 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |