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

Catalog Number FORCEFXCS

Device Problem Failure to Obtain Sample (2533)

Patient Problem Burn(s) (1757)

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.A review of the appropriate device history records for this serial number was conducted and no entries potentially pertinent to the customer's report were noted.

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 handpiece at the time that his hand was burned.No further information has been received regarding this incident.

Manufacturer Narrative

(b)(4).One forcefxcs unit was received for evaluation.The returned sample met specification as received by covidien.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.The investigation found the device to function normally and within specifications.The investigation could not determine the root cause of the customer's report.A review of the device history records indicated that this serial number was released meeting all specifications as manufactured.

• Brand Name: FORCE FX-8C GENERATOR (SHANGHAI)
• 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: 5795735
• MDR Text Key: 49624331
• Report Number: 3006451981-2016-00285
• 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,Followup
• Report Date: 06/20/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/13/2016
• 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