MAUDE Adverse Event Report: INTEGRA YORK, PA INC. MLX 300W XENON LIGHTSOURCE; N/A

Catalog Number 00MLX

Device Problems Overheating of Device (1437); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

It was reported that the 00mlx mlx 300 w xenon lightsource when the unit was turned on, it makes a clicking sound, and at times it will come on out of standby and sometimes it will not.It was reported that the unit was overheating.Additional information was received on 09aug2018 reporting that there was no flames or smoke.There was a 3-4 minutes delay in procedure due to product problem but no adverse reaction to the patient.The procedure was completed with a replacement lightsource.

Manufacturer Narrative

The device was returned to the manufacturer for evaluation, therefore the failure mode was confirmed.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.A visual inspection of the returned unit found user labels, there was no visible, physical damage.Functional testing found the lamp ignition was intermittent, there was extended clicking during several attempts.The test lamp was installed and immediately ignited and functioned properly.In addition, the light source ran for an additional 15 minutes in standby mode and the lamp shut "off" as designed to avoid excessive heat being generated.No overheating occurred during testing.The complaint was confirmed for the report of the light source ¿makes a clicking sound¿ but unconfirmed for the ¿unit sometimes is overheating¿.

Event Description

N/a.

• Brand Name: MLX 300W XENON LIGHTSOURCE
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 7822503
• MDR Text Key: 118576239
• Report Number: 2523190-2018-00106
• Device Sequence Number: 1
• Product Code: FCW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00MLX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1