MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2015-12-03 for FLX-LITE, STERILE, SINGLE USE, FLEXIBLE SURGICAL 3034A manufactured by Conmed Linvatec.
[32888832]
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 Sequence No: 1, Text Type: N, H10
[32888833]
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 Sequence No: 1, Text Type: D, B5
[35051680]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2015-00067 |
| MDR Report Key | 5262926 |
| Report Source | DISTRIBUTOR |
| Date Received | 2015-12-03 |
| Date of Report | 2015-11-05 |
| Date Mfgr Received | 2015-12-15 |
| Device Manufacturer Date | 2014-01-16 |
| Date Added to Maude | 2015-12-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BRENDA JOHNSON |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995515 |
| Manufacturer G1 | CONMED LINVATEC |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLX-LITE, STERILE, SINGLE USE, FLEXIBLE SURGICAL |
| Generic Name | LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED |
| Product Code | KYT |
| Date Received | 2015-12-03 |
| Catalog Number | 3034A |
| Lot Number | 0114C |
| Device Expiration Date | 2018-01-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | 11311 CONCEPT BLVD. LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-03 |