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

Model Number FORCEFX-8C

Device Problem Image Display Error/Artifact (1304)

Patient Problem Insufficient Information (4580)

Event Date 03/05/2022

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 laparoscopic adnexal cystectomy, the operation was going on for about an hour when the surgeon used the unit to stop bleeding, the surgeon found that the unit's screen suddenly flickered and could not be used normally.Immediately replaced with another unit to continue the operation.It was noted that the unit was running normally when tested before operation and at the beginning of the operation.Patient was under general anesthesia with endotracheal intubation.

• Brand Name: FORCE FX
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14675497
• MDR Text Key: 295262916
• Report Number: 1717344-2022-00722
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884524001562
• UDI-Public: 10884524001562
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K944602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORCEFX-8C
• Device Catalogue Number: FORCEFX-8C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2022
• Date Device Manufactured: 12/01/2017
• 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 Age: 32 YR
• Patient Sex: Female