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

Catalog Number 001190

Device Problems Thermal Decomposition of Device (1071); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/25/2016

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 an 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.One of 2 related complaints (2523190-2016-00058).

Manufacturer Narrative

On 4/19/16 integra investigation completed.Manufacture date unknown.Method: failure analysis, device history evaluation.Results : failure analysis - used, module only returned with retaining ring engravings that predate integra burlington.This module predates dhr from items made at the burlington facility.The module can be confirmed as being melted.The item was built prior to integra, and there are no apparent circumstances that occurred during the melting of plastic,.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: integra was unable to identify a manufacturing event that caused this issue.

• Brand Name: ASSY, MODULE ULTRALITE
• 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: 5588752
• MDR Text Key: 43171173
• Report Number: 2523190-2016-00057
• 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: 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: 001190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2016
• Initial Date FDA Received: 04/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2016
• 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