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Model Number SCDA39 |
Device Problems
Failure to Deliver Energy (1211); Failure to Cut (2587); Failure to Fire (2610); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Laceration(s) (1946); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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D10 concomitant product: scda39, ultrason dissect scda39 curved jaw 39cm (lot#: 20250108x); scg sonicision generator x1 (serial#: unknown); scg sonicision generator x1 (serial#: unknown); scb sonicision battery pack x1 (serial#: 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 procedure, the device failed to activate after fifteen minutes it begin to fail to activate with a red light on the generator.The surgeon allowed the to perform tests by disconnecting and reconnecting the entire battery and generator system, and the error persisted.The device kit (battery and generator) was replaced without success.In an attempt to continue the procedure, a new device clamp was opened with the same batch and the same problem was detected with both kits used.Due to what happened, the surgeon converted the procedure (open surgery) to completion.Laparoscopic to conventional was necessary because of a failure in the cutting and coagulation system of the device cleansers.
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Manufacturer Narrative
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Additional information: g3 correction: a1, b5, h6 (fdp/imf/ime: c172009 modified surgical procedure/ f1906 modified surgical procedure/ e2009 lacerations) 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 procedure, the device failed to activate after fifteen minutes it begin to fail to activate with a red light on the generator.The surgeon allowed the to perform tests by disconnecting and reconnecting the entire battery and generator system, and the error persisted.The device kit (battery and generator) was replaced without success.In an attempt to continue the procedure, a new device clamp was opened with the same batch and the same problem was detected with both kits used.No part of the device was detached.A new dissector was used with the same generator and battery and it worked successfully.Due to what happened, the surgeon converted the procedure (open surgery) to completion.Laparoscopic to conventional was necessary because of a failure in the cutting and coagulation system of the device cleansers.
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Manufacturer Narrative
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Additional information: h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.A video was also provided.Visual inspection noted the unit had a waveguide failure.It was reported that there was an adverse event without an identified device or use problem.The device had any issue with coagulating, had a cutting issue, received a red light and would not activate during use.A potentially related device issues were confirmed.The product analysis noted evidence that the device was not used as intended.The titanium waveguide became cracked from continued use after it may have come in contact with a metallic object.Use after damage can cause the cracked waveguide to break off.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: contact between the active blade and other metal objects (hemostats, clips, staples, retractors, etc.) may result in product damage, such as a broken blade.Pieces of a broken blade may fall into the surgical cavity causing unintended tissue damage.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 procedure, the device failed to activate.After fifteen minutes, it begin to fail to activate with a red light on the generator.The surgeon allowed to perform tests by disconnecting and reconnecting the entire battery and generator system, and the error persisted.The device kit (battery and generator) was replaced without success.In an attempt to continue the procedure, a new device clamp was opened with the same batch and the same problem was detected with both kits used.Due to what happened, the surgeon converted the procedure (open surgery) to completion.Laparoscopic to conventional was necessary because of a failure in the cutting and coagulation system of the device cleansers.No part of the device was detached.The procedure stopped for 15 minutes.The procedure was completed via product exchanged.
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Search Alerts/Recalls
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