MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS FORCE FX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number FORCEFX-8CS

Device Problems Fire (1245); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during procedure, there was fire on the unit's receptacle.There was no patient injury.

Manufacturer Narrative

Evaluation summary: pictures were received for evaluation.The returned sample did not meet specification as received.Details regarding a visual inspection were not provided but the pictures provided show heat related damage to the front panel and monopolar receptacle.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.The investigation found that the unit passed performance verification tests.The picture sample provided by the customer shows heat related damage to the monopolar receptacle and front panel.The investigation found that the front panel needs to be replaced.The investigation could not determine a root cause or a probable root cause for the customer's report based on the information provided.Details regarding the repair were not provided.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during an ears, nose and throat (ent) procedure, there was fire on the unit's monopolar 1 receptacle.The fire was extinguished with scrub cloth.Another unit was used to complete the procedure.There was no patient injury.

• Brand Name: FORCE FX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 9532719
• MDR Text Key: 173108874
• Report Number: 3006451981-2019-00261
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524002590
• UDI-Public: 10884524002590
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K944602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORCEFX-8CS
• Device Catalogue Number: FORCEFX-8CS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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