MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ASSY, CABLE ULTRALITE 2 BIFURC; N/A

Catalog Number 0029009

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 03/25/2016

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Light module was being used with a mlx lightsource, and surgeon noticed the light module was burning and took off headlight to see a hole burned through the bottom.On (b)(6) 2016 customer reports this occurred during ent procedure, no further information available, no harm done.Two of 2 related complaints (2523190-2016-00057).

Manufacturer Narrative

On 6/30/16 integra investigation completed.Method: failure analysis, device history evaluation results: failure analysis - complaint is unconfirmed; this is due to the product not being returned for review.Device history evaluation - nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order / manufacturing change order history: none.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.

• Brand Name: ASSY, CABLE ULTRALITE 2 BIFURC
• Type of Device: N/A
• 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: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5586678
• MDR Text Key: 42973199
• Report Number: 2523190-2016-00058
• Device Sequence Number: 1
• Product Code: FST
• Combination Product (y/n): N
• PMA/PMN Number: K8643780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 0029009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2016
• Initial Date FDA Received: 04/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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