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

Catalog Number 001388LX9

Device Problem Thermal Decomposition of Device (1071)

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

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

Customer initially reports cable end-fitting burned by mlx.On (b)(6) 2016 customer reports issue was found during an open gallbladder, about halfway through the procedure, no harm to patient.No further information available.#2 of 2 related devices.

Manufacturer Narrative

On 11/30/16 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - there was a ul pro fused cable returned because the end fitting was burnt by the mlx light source.There is no deficiency identified with the cable.The light source cause the damage to the cable.Without the light source it cannot be determined why light source generated enough heat to damage the cable.The complaint can be confirmed, 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.Repair history: n/a.Conclusion: there is no deficiency identified with the cable.The root cause can not be determined.

• 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: 6121017
• MDR Text Key: 60691812
• Report Number: 2523190-2016-00197
• 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: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 001388LX9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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