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

Catalog Number 600290

Device Problem Fire (1245)

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

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

On 6/12/2017 integra investigation completed.Method: failure analysis, device history evaluation: results: failure analysis - one monopolar cable returned in used condition, showing minimal wear.There is a break in the cord.It appears there might have been damage to this area prior to the fire, there is blue tape on the cord right where the fire began.This item is from an old design we no longer have this item in production.Device history evaluation - dhr review: nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: there is no applicable variance authorization / deviation history.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: for cable damage leading to safety hazards (fires, sparks, smoke).Conclusion : the complaint report of damage has been confirmed; the root cause of the damage has not been identified as a workmanship or material deficiency.

Event Description

Customer initially reports a patient related fire incident.Physician was operating with l-hook and grey cord.The grey cord started a fire during surgery.Cable split in half and burned through foam arm rest.Patient was unharmed.On (b)(6)17 customer reports event occurred during a laparoscopic cholecystectomy.

• 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: 6638506
• MDR Text Key: 77496726
• Report Number: 2523190-2017-00066
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• PMA/PMN Number: K120012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 600290
• Device Lot Number: 100197-1411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2014
• 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: 44 YR