Model Number 173016 |
Device Problems
Break (1069); Component or Accessory Incompatibility (2897); Human-Device Interface Problem (2949)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/30/2024 |
Event Type
malfunction
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Manufacturer Narrative
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D10 concomitant product: 173016 - 173016 endo stitch instrument, lot# j1g2253ey unknown endo st - unknown endo stitch sulu, lot# unknown.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 total hysterectomy procedure, the first device that was used was unable to load and would not hold stitch.Then, a second device was opened and used; it would not load either, and the switching device broke.The surgical procedure was delayed by 15 minutes due to attempts to load and change instruments.After two device attempts, it was changed to suture closure to resolve the issue.
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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 available for evaluation.Visual inspection noted no witness marks from the needle tip impacting the beveled walls.The flat pin was properly oriented.The instrument had a broken toggle switch.No abnormalities were observed for the center rod and for the metal blades of the instrument.It was reported that the device was difficult to load, difficult to toggle, and the instrument broke.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.These issues may occur during the inability of the user to unload or toggle the needle, causing the user to exert excessive force on the toggle switch which results in breaking of the toggle switch either at the use button or at the part that contacts the flat pin.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: ensure that the toggle levers are fully retracted prior to opening the jaws of the device.The reloading button should never be pressed when the instrument is in the body cavity, as this will release the needle.Inspect the application site to ensure hemostasis.Place additional sutures or use electrocautery if necessary to complete hemostasis.Endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic techniques.A thorough understanding of the operating principles, risks versus benefits, and the hazards involved in utilizing an endoscopic approach is necessary to avoid possible injury to the user and/or patient.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 total hysterectomy procedure, the first device that was used was unable to load and would not hold stitch.Then, a second device was opened and used; it would not load and was difficult to toggle either, and the switching device was physically broken.The surgical procedure was delayed by 15 minutes due to attempts to load and change instruments.After two device attempts, it was changed to suture closure to resolve the issue.
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Search Alerts/Recalls
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