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

Model Number	FORCEEZ-8C
Medical Device Problem Codes	Break (1069); Image Display Error/Artifact (1304); Adverse Event Without Identified Device or Use Problem (2993); Intermittent Energy Output (4025)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during a laparoscopic cholecystectomy for patient with multiple gallstones and cholecystitis, the unit suddenly lost power during use, and the screen had no display.After checking the power cord and power interface, there was no abnormality.The panel was turned on and off again and the display was restored, but the power outage occurred again in a short time.Stopped using the electrosurgical generator in the operating room and replaced it with another electrosurgical generator to continue the surgery on the patient.It resulted in prolonged surgery and anesthesia time.Patient had serious injury.
Event or Problem Description
According to the reporter, during a laparoscopic cholecystectomy for patient with multiple gallstones and cholecystitis, the unit suddenly lost power during use, and the screen had no display.After checking the power cord and power interface, there was no abnormality.The panel was turned on and off again and the display was restored, but the power outage occurred again in a short time.Stopped using the electrosurgical generator in the operating room and replaced it with another electrosurgical generator to continue the surgery on the patient.It resulted in prolonged surgery and anesthesia time.
Additional Manufacturer Narrative
Additional information: b1, b2 (removed), b5, g3, h1, h6 (imf) new information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a malfunction.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: FORCE EZ
• Common Device Name: 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20350732
• Report Number: 1717344-2024-01909
• Device Sequence Number: 15414549
• Product Code: GEI
• UDI-Device Identifier: 10884521512085
• UDI-Public: 10884521512085
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K944602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FORCEEZ-8C
• Device Catalogue Number: FORCEEZ-8C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/07/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male