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

Catalog Number 600290

Device Problems Thermal Decomposition of Device (1071); Fire (1245)

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

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Nurse checked the connection, dr wanted it turned up, turned it up to 50 coag and 50 cut.Dr stated device was working better.Circulator heard a loud pop and the monopolar cord was on fire.The cord burnt all of the way through and fell to the floor.No drapes caught fire.The end that was still in the machine was pulled out.A new monopolar cord was obtained and the case went on as planned with no problems.No harm done.Case# 1 of 2.

Manufacturer Narrative

3/31/2016 integra investigation completed.Manufacture date unknown.Method : failure analysis, device history evaluation.Results : failure analysis.Mono polar cord returned used, showing no unusual markings and severed in half.Upon further investigation, it is noticed that the cord has been burned/melted and broken in half.There were two incidents with this customer.There was only one cord sent back due to the first cord being thrown away.This item has been discontinued.The complaint report is confirmed.Device history evaluation: dhr review was completed with all history available.Nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: created a new part number for this discontinued item.Corrective action preventive action history: issued (b)(6) 2013 for cable damage resulting in fire or a potential to start a fire.Conclusion: there was a mono polar cord returned showing no unusual markings and severed in half.The complaint report is confirmed; root cause undetermined.

• 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: 5516248
• MDR Text Key: 40868599
• Report Number: 2523190-2016-00030
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 600290
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2016
• 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
• Patient Age: 68 YR