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Model Number 21-345 |
Device Problems
Product Quality Problem (1506); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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D10 concomitant product: 21-345, 21-345 clearify visualization system (lot#d3e1868y); 21-345, 21-345 clearify visualization system (lot#d3e1868y); 21-345, 21-345 clearify visualization system (lot#d3g2767y); 21-345, 21-345 clearify visualization system (lot#d3g2767y); 21-345, 21-345 clearify visualization system (lot#d3g2767y); 21-345, 21-345 clearify visualization system (lot#d3g2767y); 21-345, 21-345 clearify visualization system (lot#d3g2767y); 21-345, 21-345 clearify visualization system (lot#d3c0949y); 21-345, 21-345 clearify visualization system (lot#d3c0949y); 21-345, 21-345 clearify visualization system (lot#d3c0949y); 21-345, 21-345 clearify visualization system (lot#d3e2922y).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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Event Description
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According to the reporter, during a laparoscopic cholecystectomy procedure, the device did not turn on.Additional devices were opened to find more contaminated with brown crusty rust inside.A new device was used to resolve the issue.The surgical time was extended by 40 minutes due to the device problem.
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Manufacturer Narrative
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H3 evaluation summary: medtronic conducted an investigation based upon all information received.Two devices were available for evaluation.Visual inspection found no abnormalities to the foam body.The valves were opened and the surfactants were gone.Functionally, the tactile inspection of the power switch confirmed that the switch was fully activated.The device was dismantled, the foam body was torn to expose internal components.The device batteries were drained.Brown stains on the inside of the foam body and near the seal was observed.It was reported that there was a medical complication.The reported issue could not be confirmed.The most likely cause could not be established from the information available.It was also reported that the device was contaminated with brown crusty rust inside.The reported issue was confirmed.The most likely cause was traced to device design.Internal process improvements have been initiated to mitigate this issue.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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Search Alerts/Recalls
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