MAUDE Adverse Event Report: INTEGRA YORK, PA INC. MONOPOLAR CABLE 10 FEET; ELECTROSURGICAL COAGULATION

Catalog Number 600290

Device Problems Electrical /Electronic Property Problem (1198); Fire (1245)

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

Event Date 12/07/2015

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 medwatch# (b)(4) reports that during a davinci robotic case, the laparoscopic cautery cord caught fire.The surgical assistant saw the cautery cord catch fire and the nurse removed the cord from cautery unit.Once the cautery cord plug was removed from the unit, the fire went out.The fire did not spread beyond the cord.1/20/16 customer reports they don't know procedure name.No harm to patient or staff.

Manufacturer Narrative

On 3/31/16 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - unable to perform failure analysis due to the product not being returned for evaluation.Device history evaluation - nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order / manufacturing change order history: no related orders.Corrective action preventive action history: (b)(4) for cords catching fire health hazard evaluation history: (b)(4) for cords catching fire repair history: na.Conclusion: unable to perform root cause analysis due to the product not being returned for evaluation.

• Brand Name: MONOPOLAR CABLE 10 FEET
• Type of Device: ELECTROSURGICAL COAGULATION
• 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: 5400034
• MDR Text Key: 37176872
• Report Number: 2523190-2016-00007
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• PMA/PMN Number: K932456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 600290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2016
• 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