MAUDE Adverse Event Report: INTEGRA YORK, PA INC. LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - AU; LIGHTING

Catalog Number 90520AU

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 04/12/2016

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

No light output.Burning smell from headlight pcb (printed circuit board).There was no delay to surgery and no medical intervention was required.No patient injury or harm.No adverse event reported.

Manufacturer Narrative

On 6/17/2016 integra investigation completed.Manufacture date unknown.Method: failure analysis, device history evaluation.Results: failure analysis - (b)(4) service centre.Evaluation summary: the reported complaint could not be replicated in service centre, after over 10 hours operation.Light output is acceptable, and burning smell is not evident.Internally no components are damaged.Conclusion: unconfirmed complaint; could not be duplicated.Evaluation in billerica repair depot: a visual inspection found no visible, physical damage.Inspection of the printed circuit board in the rear module assembly also, found no visible damage or burnt or broken components.The led headlight was functionally tested an additional 30 minutes.There was no burning smell and the unit functioned as intended.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: the complaint was unconfirmed, unit was operated over 10 hours with no evidence of a burning smell.Internal components also revealed no evidence of burning or overheating.

• Brand Name: LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - AU
• Type of Device: LIGHTING
• 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: 5640733
• MDR Text Key: 45001842
• Report Number: 2523190-2016-00064
• Device Sequence Number: 1
• Product Code: FSR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

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: 90520AU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2016
• 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