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)

Patient Problem Burn(s) (1757)

Event Date 12/15/2016

Event Type  Injury  

Event Description

It was reported that connection between the premium cable and ultralight pro headlamp melted and burned surgeon.Device was not in contact with patient, no patient injury/ death alleged, no medical intervention required, patient was prepped for the surgery, 5 minutes delay in surgery due to product problem.

Manufacturer Narrative

On 1/17/17 integra investigation completed.Manufacture date not known.Method: failure analysis, device history evaluation results: failure analysis - there was a premium fiber optic cable and non integra headlight returned because the headlamp melted and burned the surgeon.A visual inspection showed the cable was used and had visible damage.The damage consisted of a loose connector on the light source end and a melted luminaire on the headlamp end.There was no heat damage to the light source end.The quality of the non integra headlight is not known, so there is no way of knowing if the headlight was compatible with this cable.All of the damage to cable seems to have come from the melted headlight.There is no evidence the cable has failed.The complaint is unconfirmed.Device history evaluation - nonconforming product report / nonconforming material report history: none related.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history/corrections: none.Health hazard evaluation history: none.Repair history: none.Conclusion: all of the damage to cable seems to have come from the melted headlight.There is no evidence the cable has failed.

• 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: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6239315
• MDR Text Key: 64427170
• Report Number: 2523190-2017-00003
• Device Sequence Number: 1
• Product Code: FST
• Combination Product (y/n): N
• PMA/PMN Number: K071218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 001388LX9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2017
• 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
• Patient Outcome(s): Other