MAUDE Adverse Event Report: COVIDIEN LLC FORCE FX-8C GENERATOR; ELECTROSURGICAL GENERATOR

Catalog Number FORCEFXCS

Device Problem Failure to Obtain Sample (2533)

Patient Problem Burn(s) (1757)

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) date of initial report : 07/14/2016.To date the unit has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The customer reported that the forcefx8c generator was in use for a procedure during which the surgeon received a burn to his hand.The degree and treatment of the burn is unknown.The surgeon had been using a non-covidien electrosurgical pencil at the time that his hand was burned.No further information has been received regarding this incident.

• Brand Name: FORCE FX-8C GENERATOR
• Type of Device: ELECTROSURGICAL GENERATOR
• Manufacturer (Section D): COVIDIEN LLC; bldg 10, 789 puxing rd; shanghai 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN LLC; bldg 10, 789 puxing rd; shanghai 20111 4; CH 201114
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 5795421
• MDR Text Key: 49574019
• Report Number: 3006451981-2016-00284
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K944602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FORCEFXCS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2016
• Initial Date FDA Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BLAYCO ELECTROSURGICAL PENCIL.