MAUDE Adverse Event Report: INTEGRA YORK, PA INC. UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM; CABLES

Catalog Number 001388LX9

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2019

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.Linked to mfg report number: 2523190-2019-00093.

Event Description

It was reported that on (b)(6) 2019, a brand new cable 001388lx9 ul pro fused headlight cable 9ft, 275cm melted, burned and browned when using the 00mlx mlx 300w xenon lightsource.There was no patient contact, injury, or surgery delay reported.

Manufacturer Narrative

The device was returned to the manufacturer for physical evaluation.A visual inspection of the returned 001388lx9 pro fused fiber optic cable found a deep crease in the jacket approximately 3 inches from the connector at the distal end.Functional testing found the cables exhibited a slight brown color at each end.The reported complaint was confirmed.The fiber ends sustained melting-damaged due to exposure from excessive use from the mlx light source.No manufacturing, workmanship, or material deficiency has been identified.Device identifier: (b)(4).

Event Description

N/a.

• Brand Name: UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM
• Type of Device: CABLES
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: kimberly shelly ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 8785674
• MDR Text Key: 150860612
• Report Number: 2523190-2019-00092
• Device Sequence Number: 1
• Product Code: FST
• Combination Product (y/n): N
• PMA/PMN Number: K864380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 001388LX9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MLX LIGHT SOURCE