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

Catalog Number	00MLX
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A senior service engineer reported that the 00mlx mlx 300w xenon lightsource overheated during installation at a hospital.The mlx machine was switched on and the intensity increased to 20 % to 95%.The fiber optic cable connector glass was damaged due to the overheat.The mlx lightsource was checked with another fiber optic cable, which was also damaged, hence two (2) fiber optic cables were defective.It was unknown if there was patient contact, injury, or a surgical delay.Additional information has been requested.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.There were no deviations or non-conformances during the manufacturing process.A failure analysis and determination of root cause is not possible because the product has not been returned.The reported complaint is unconfirmed.Device identifier: (b)(4).
Additional Manufacturer Narrative
Device identifier: (b)(4).The product was returned for evaluation and was found with two used/damaged fiber optic cables.The unit was set at 100% for approximately 15 minutes with an undamaged fiber optic cord attached.Upon completion of the test, the cord's lens was undamaged.Based on the results of the investigation, the reported issue is not confirmed.The unit tests within defined specification.

• Brand Name: MLX 300W XENON LIGHTSOURCE
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 8684384
• Report Number: 2523190-2019-00081
• Device Sequence Number: 2309134
• Product Code: FCW
• UDI-Device Identifier: 10381780167969
• UDI-Public: 10381780167969
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00MLX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 06/10/2019; 09/10/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 06/14/2019; 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1