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Model Number LF1837 |
Device Problems
Energy Output Problem (1431); Appropriate Term/Code Not Available (3191)
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Patient Problem
Insufficient Information (4580)
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Event Date 10/24/2023 |
Event Type
Injury
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Manufacturer Narrative
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D10 concomitant product: lf5637, ligasure lf5637 retractable l hook (lot#: 30880237x); lf1837, blunt tip sealer divider lf1837 (lot#: 31570270x); forcetriad force triad energy platform (serial#: (b)(6)); forcetriad force triad energy platform (serial#: (b)(6)); vlft10gen ft series energy platformx1 (serial#: (b)(6)).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 sigmoidectomy, the device sealed about 3 or 4mm fatty tissue and there was no re-grasp alert but with activation tone and end tone, but device did not seal.Without cleaning, the device failed from the first attempt.Switched to another device and did absolutely the same thing, not sealing the tissue.Another device was opened and did not work either.The three devices were tested on three different generators and the result was the same.An applied device was also used and did not work correctly either.Finally, the surgery was canceled and performed after four days.Another device used successfully with the same generator.Re-operation or additional surgical was performed and patient had extended hospitalization.
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Manufacturer Narrative
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H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted a seal cycle was initiated thermal effects were visually verified.End tones were heard, and the device did not seal completely.Functionally, the device was detected and activated multiple times on a saline soaked gauze pad with satisfactory results.All seal cycles were completed satisfactorily and end tones were heard indicating completed activation cycles.The device sealing performance was tested on porcine kidney tissue.Multiple seals on various size vessels were made and a full thermal effect was visually verified.The sealing was adequate when the seal cycle reached end tone.It was reported that the device was not sealing the tissue.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.The instructions included with this device provide the following guidance: avoid grasping objects, such as staples, clips, or encapsulated sutures in the jaws of the instrument.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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