MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES

Model Number E6008B

Device Problems Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, intra-operatively, the device¿s foot pedal had no coagulation output.As a result, the procedure was interrupted.There was no patient injury.

• Brand Name: VALLEYLAB
• Type of Device: UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 7176322
• MDR Text Key: 96835987
• Report Number: 1717344-2018-00037
• Device Sequence Number: 1
• Product Code: BWA
• UDI-Device Identifier: 10884524001647
• UDI-Public: 10884524001647
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K874794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E6008B
• Device Catalogue Number: E6008B
• Device Lot Number: 187953/3X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2017
• 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 Outcome(s): Other