MAUDE Adverse Event Report: CONMED LINVATEC FLX-LITE, STERILE, SINGLE USE, FLEXIBLE SURGICAL; LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED

Catalog Number 3034A

Device Problems Sparking (2595); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: FLX-LITE, STERILE, SINGLE USE, FLEXIBLE SURGICAL
• Type of Device: LIGHT, EXAMINATION, MEDICAL, BATTERY POWERED
• Manufacturer (Section D): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5262926
• MDR Text Key: 32888832
• Report Number: 1017294-2015-00067
• Device Sequence Number: 1
• Product Code: KYT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2018
• Device Catalogue Number: 3034A
• Device Lot Number: 0114C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1