FDA Adverse Event
Other
Summary report: N
SURGAIRTOME TWO HANDPIECE
MDR report key: 1213728
·
Received October 23, 2008
Report
- Report Number
- 1017294-2008-00333
- Event Type
- Other
- Date Received
- October 23, 2008
- Date of Event
- October 2, 2008
- Report Date
- October 2, 2008
- Manufacturer
- CONMED LINVATEC
- Product Code
- HBC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS LOANER HANDPIECE FOR EVALUATION. DURING TESTING OF THE HANDPIECE, THE REPORTED PROBLEM OF OVERHEATING WAS UNABLE TO BE DUPLICATED, AS THE DEVICE OPERATED TO MANUFACTURER TEMPERATURE SPECIFICATION. FURTHER INVESTIGATION FOUND THIS UNIT WITHIN THE PREVENTIVE MAINTENANCE SCHEDULE; LAST REPAIR JULY 31, 2008. ASSOCIATED MDR#: 1017294-2008-00334.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING USE OF THIS LOANER HANDPIECE TO PERFORM A THIRD MOLAR EXTRACTION, THE PT RECEIVED A BURN TO THE RIGHT LOWER LIP. THE AFFECTED AREA WAS TREATED WITH NEOSPORIN OINTMENT. THE CUSTOMER REPORTED THAT NO RESIDUAL AFFECTS RESULTED FROM THIS EVENT, AS NOTED ON THE PT'S FOLLOW-UP APPOINTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGAIRTOME TWO HANDPIECE | HIGH SPEED DRILL | HBC | CONMED LINVATEC | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NK | Required Intervention | MEDIUM BUR GUARD |