COVIDIEN MFG DC BOULDER VALLEYLAB FT10; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number VLFT10GEN |
Device Problems
Self-Activation or Keying (1557); Material Integrity Problem (2978)
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Patient Problem
Burn(s) (1757)
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Event Date 11/14/2023 |
Event Type
malfunction
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Event Description
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According to the reporter, during laparoscopic procedure, the nurse was able to place bipolar cord into monopolar 1 port on generator, software version sw 4.0.2, which then immediately started activation of monopolar current through bipolar instrument.The bipolar wire was connected to the monopolar input.The power line was connected to bipolar pliers, and current flowed through the pliers without the foot pedal being activated.Self-activation happened without pressing/ pushing of activation button.The biomed checked and confirmed that this was possible, and that it will immediately activate when power setting was at normal level.The monopolar 1 port accept bipolar cords from a different brand.The bipolar cord used during the reported incident was an old and well used one from a different brand.The generator used during the incident was new and the monopolar 1 port was not considered to be worn by the biomed.The event was caused by a misplacement of the bipolar plug, into the monopolar port, and that the issue was not isolated to the specific generator itself.The biomed concludes that three security rules was not met from the or staff; cable with instrument was put into wrong port by mistake, but sees it as unfortunate that this was possible.Instrument was stored unprotected on patient.Activation sound put on low level and ignored.The generator was not replaced during the procedure, but the bipolar plug was replaced from the monopolar to the bipolar port and the procedure was completed as normal.A photo was attached showing a damaged cord.The patient had a small scar on stomach from small skin burn damage, they used bandage as treatment done to the burn site.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted that the bipolar instrument was plugged into the monopolar port.A comprehensive examination could not be performed, because the returned sample was not received in a state that allowed full functional or visual assessment.It was reported that the nurse was able to place a bipolar cord into the monopolar 1 port on valleylab ft10 generator, which then immediately started activation of monopolar current through the bipolar instrument.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.
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