MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER FORCE FX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number FORCEFXC

Device Problems Inaccurate Delivery (2339); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the unit had issues with rem alarm and was making an odd sound.

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.The returned sample did not meet specification as received.The visual inspection found that the front feet were missing; minor cosmetic wear on most of the unit; and a very worn keypad.Unit missing 2 inserts on the front end of unit, had already been replaced once not able to replace again.The investigation found that the right side red light emitting diode (led) of the return electrode monitoring (rem) alarm was very dim.Rem was tested and the unit passed rem testing.The investigation identified the cause of the reported event to be the display pcba.The display pcba was replaced to address the condition.The investigation also found that a static sound was observed from the speaker during volume change.After several cycles, static sound cleared and was not observed again.The investigation could not determine a root cause or a probable root cause for the customer's report based on the information provided.The keyboards recall and fulgurate keys were very weak.Issue with fulgurate not engaging properly.The investigation identified the cause of the reported event to be the keypad.The unit's fuse clips showed heavy discoloration, and a few were loose in the psrf pcba.The investigation identified the cause of the reported event to be the fuse clips.All 8 fuse clips were replaced to address the condition.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: FORCE FX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & 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: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 9563456
• MDR Text Key: 174381323
• Report Number: 1717344-2020-00036
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524002613
• UDI-Public: 10884524002613
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2020

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 Model Number: FORCEFXC
• Device Catalogue Number: FORCEFXC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 01/21/2020; 04/15/2020
• Supplement Dates FDA Received: 02/03/2020; 04/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2006
• 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