Model Number 173016 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2022 |
Event Type
malfunction
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Event Description
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According to the reporter, on a laparoscopic roux-en-y gastric bypass and hiatal hernia repair, during the creation of side-to-side anastomosis, the devices had unloading difficulties.The needles broke, disengaged from the handle, and fell into the patient¿s cavity.The needles were retrieved with a laparoscopic grasper.A single-use suturing device was used instead.There was no patient injury.
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Manufacturer Narrative
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Concomitant medical products: 173016 173016 endo stitch instrument lot # j2g0204ey 173016 173016 endo stitch instrument lot # j2c0598ey 170044 170044 endo stitch tri 2-0 grn 120 s'dac lot # j2b2352y 170044 170044 endo stitch tri 2-0 grn 120 s'dac lot # j2b2352y 170044 170044 endo stitch tri 2-0 grn 120 s'dac lot # j2b2352y.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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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.
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Event Description
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According to the reporter, on a laparoscopic roux-en-y gastric bypass and hiatal hernia repair, during the creation of side-to-side anastomosis, the devices had unloading difficulties.Three needles broke, disengaged from the handle, and fell into the patient¿s cavity.All three needles were retrieved with a laparoscopic grasper.A single-use suturing device was used instead.There was no patient injury.
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Manufacturer Narrative
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Additional information: a1, d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the loading button was disengaged.Microscopic inspection of the loading button noted deformations.Functionally, the blades of the device were straightened.The returned device was loaded with a test needle from the inventory and applied to test media.The test needle remained intact throughout testing.No difficulty was experienced in loading and toggling the test needle in the returned device.Difficulty was experienced in unloading the needle because the plunger had to be manually activated due to the absence of the unloading button.It was reported that the device was difficult to unload.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur during the inability of the user to unload an improperly loaded needle which might cause the necessity to exert pressure on the button which results in it disengaging or breaking.It was also reported that the needle broke into separate pieces, and fell out of the jaws of the device.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the blades of the instrument were bent.The product analysis noted evidence that the device was not used as intended.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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Search Alerts/Recalls
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