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

Model Number	FORCEFX-8CAS
Medical Device Problem Codes	Inaccurate Delivery (2339); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection found no notable conditions.The evaluation found that the low voltage power supply and k2 relay were worn.The issue was resolved by replacing the low voltage power supply and k2 relay.It was reported that the device had an unknown failure.The reported issue was confirmed.The most likely cause was traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during servicing, random defect of patient plate went green even without a plate.The date of the error log was corrupted.Error 160 in the log immediately before the corrupted date.The unit also had worn k2 relay.There was no patient involvement.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, random defect of patient plate.Goes green even without a plate.The date of the error log is corrupted.Error 160 in the log immediately before the corrupted date.The unit also had worn k2 relay.

• Brand Name: FORCE FX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• MDR Report Key: 11893602
• Report Number: 3006451981-2021-00068
• Device Sequence Number: 11670996
• Product Code: GEI
• UDI-Device Identifier: 10884524002637
• UDI-Public: 10884524002637
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: FORCEFX-8CAS
• Device Catalogue Number: FORCEFX-8CAS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1