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Model Number SIGADAPTXL |
Device Problems
Entrapment of Device (1212); 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 10/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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D10 concomitant product: sigphandle, sig power sigphandle handle (serial#: unknown); unknown endo gia 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 gastric bypass procedure, when the first tri stapler reload was assembled to the stem to start dissection of the antrum, when the reload was assembled and proceed to enter the cavity to take a section of the antro from the stomach, the closure of the jaws was active and blocked through stem error signal on the screen, when about to open the jaws and removing, the recharge did not responds, an attempt to restart restart the device without being able to unlock the recharge, the user proceed to disconnect the stem and use the retraction tool to open the reloading jaw, once achieved the reload was removed from the stem and is was too tight.It was also noted that the device lock of tissue.Another reload was use the same issue incident, force loading to assemble and disconnect.The user change the standard adapter and continue the procedure with issue.There was no patient injury.
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Manufacturer Narrative
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Concomitant product: egia60amt egia 60 artic med thick sulu (lot#: p3c0443).H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a representative reload were available for evaluation.Visual inspection noted the unload switch was at the home position and there was no damage to the adapter.Functionally, the adapter was then connected to the gen2 adapter black box running gen2 acc software and the strain gauge was responsive.The adapter had 49 of 50 procedures remaining.The adapter was connected to a representative rpa handle running v29.5 software and the device calibrated correctly.A representative reload was attached to the adapter and was able to be loaded without difficulty, but difficulty was experienced while unloading the reload.The adapter was opened up and found that the rotating ring was out of position.Additional functional testing was precluded due to the rotating ring being out of position.It was reported that there was difficulty to load and instrument locked on tissue.The reported issue could not be confirmed.The most likely cause could not be established from the information available.It was also reported that there was difficulty to unload the device.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if the rotating ring is inadvertently moved out of position by improperly loading the reload.It is important to make sure the load arrow of the reload aligns with the load arrow of the adapter when connecting the reload into the adapter.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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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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Event Description
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According to the reporter, during a laparoscopic gastric bypass procedure, when the first tri stapler reload was assembled to the stem to start dissection of the antrum, when the reload was assembled and proceed to enter the cavity to take a section of the antro from the stomach, the closure of the jaws was active and blocked through stem error signal on the screen, when about to open the jaws and removing, the recharge did not responds, an attempt to restart restart the device without being able to unlock the recharge, the user proceed to disconnect the stem and use the retraction tool to open the reloading jaw, once achieved the reload was removed from the stem and is was too tight.It was also noted that the device lock of tissue.Another reload was use the same issue incident, force loading to assemble and disconnect.The user change the standard adapter and continue the procedure without issue.There was no patient injury.
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Search Alerts/Recalls
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