| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FLX-LITE, STERILE, SINGLE USE, FLEXIBLE SURGICAL | LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED | CONMED LINVATEC | KYT | 3034A | 0114C | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-12-03 | 0 |
Patient 1
AS OF THIS FILING, THE DAMAGED EXAMINATION LIGHT HAS NOT YET BEEN RETURNED/RECEIVED FROM THE USER FACILITY FOR EVALUATION. THE INVESTIGATION REMAINS IN PROCESS. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED UPON THE COMPLETION OF THE INVESTIGATION.
Patient 1
THE CUSTOMER REPORTED THAT WHILE PREPARING TO INTUBATE A PATIENT AND GETTING THE FLEX-LITE, STERILE PREPARED, THE LIGHT BULB POPPED AND SPARKS CAME OUT FOR A FEW SECONDS WHEN THE LIGHT BULB WAS ACTIVATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO INJURY.
Patient 1
CONMED HAS BEEN ADVISED BY THE DISTRIBUTOR THAT THE DEVICE HAS BEEN LOST AND WILL NOT BE RETURNED. WITHOUT THE ACTUAL PRODUCT, AN EVALUATION COULD NOT BE PERFORMED AND THE ROOT CAUSE OF THE ALLEGED PROBLEM WAS UNABLE TO BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT WAS MANUFACTURED ON 16-JAN-2014 IN A LOT OF (B)(4) UNITS. THERE WERE NO DISCREPANCIES NOTED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED BREAKAGE. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS RECEIVED FOR THIS ITEM AND LOT NUMBER COMBINATION. A TWO-YEAR REVIEW OF COMPLAINT HISTORY SHOWS NO OTHER SIMILAR COMPLAINTS FOR THIS ITEM. A SUPPLIER CORRECTIVE ACTION HAS BEEN GENERATED TO ADDRESS THE REPORTED ISSUE. ADDITIONALLY, THE SUPPLIER IS UPDATING THE DFMEA TO ADDRESS THE RISK OF THE BULB POPPING UPON ACTIVATION. ACCORDING TO THE SUPPLIER, THERE HAS BEEN NO PREVIOUS REPORT FOR THIS DEVICE FAILURE MODE. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING CONTRAINDICATIONS AND CAUTIONS: - THIS DEVICE IS CONTRAINDICATED FOR USE IN THE PRESENCE OF FLAMMABLE GASSES OR OTHER MATERIALS CAPABLE OF IGNITION. - DO NOT USE IF PACKAGE IS DAMAGED OR OPENED. - AVOID HAVING BULB MAKE CONTACT WITH HARD OBJECTS. DISTRIBUTOR LOST DEVICE.