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

Catalog Number 001388LX9

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2018

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

A customer reported that on (b)(6) 2018, the 001388lx9 ul pro fused headlight cable was burning when using a mlx.The cable was smelling like it was burning and it was making the mlx light source overheat.It is unknown if device was in contact with the patient.There is no information provided regarding patient injury or death alleged and delay in the surgery.Additional information has been requested.

Manufacturer Narrative

The product was not sent in to the manufacturer for evaluation.No failure analysis and determination of root cause could be determined.The complaint could not be verified given that a product sample was not returned to verify the complaint.Udi # (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
• MDR Report Key: 8190074
• MDR Text Key: 131178714
• Report Number: 2523190-2018-00187
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 001388LX9
• Device Lot Number: 10027319
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MLX LIGHTSOURCE; MLX LIGHTSOURCE