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 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6) integra investigation completed.Failure analysis, device history evaluation.Failure analysis - complaint is unconfirmed; this is due to the product not being returned for review.Complaint will be reopened if product is received.Device history evaluation - device history reviewed and there were no anomalies found for reported incident.Root cause cannot be determined due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.

Event Description

Customer initially reports the item is sparking and blowing the cord apart where it plugs into the generator.On (b)(6) customer reports laparoscopic robot assisted low anterior colon resection in progress, patient was not harmed.

• 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: 7045193
• MDR Text Key: 92509209
• Report Number: 2523190-2017-00138
• 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
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• 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: 10/27/2017
• 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
• Patient Age: 70 YR