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

Catalog Number 600290

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the monopolar cable (product id 600290) cord sparked and caught fire in the operating room during an unspecified laparoscopic procedure.It was plugged into a valley lab electrosurgical generator and attached to a bipolar forceps.There was no patient injury and no delay in surgery.

Manufacturer Narrative

Monopolar cable (product id 600290) was not returned for evaluation; however, images were provided and evaluated.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The reported complaint is confirmed.Per the provided images, the cable had melted off at the end.Per the safety label: "inspect cord prior to each use for cracks/separation.Incorrect handling of the cord can cause sparks/fire hazard." no manufacturing, workmanship or material deficiency has been identified.

Event Description

N/a.

• 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
• MDR Report Key: 11337454
• MDR Text Key: 232171493
• Report Number: 2523190-2021-00034
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• 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
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIPOLAR FORCEPS; VALLEY LAB ELECTROSURGICAL GENERATOR; BIPOLAR FORCEPS; VALLEY LAB ELECTROSURGICAL GENERATOR