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Model Number SC-5637G |
Device Problems
Break (1069); Entrapment of Device (1212); Dull, Blunt (2407)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 07/30/2019 |
Event Type
Injury
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Manufacturer Narrative
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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 procedure, when doing a subcuticular closure on patient, the needle used was very dull.The healthcare professional could not pass the needle and she noticed that the tip was broken off.It was also reported that they were unable to find the tiny missing tip of the needle.Another suture was opened and the tip was inspected and was noted to have a sharp appearance.An attempt was made using the second suture, however the result was the same as the first suture, wherein it broke off only this time the broken tip was located and removed from the patient.A third suture was used to complete the procedure.
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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.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 appendectomy procedure, when doing a subcuticular closure on patient, the needle used was very dull.The healthcare professional could not pass the needle and she noticed that the tip was broken off.It was also reported that they were unable to find the tiny missing tip of the needle.Another suture was opened and the tip was inspected and was noted to have a sharp appearance.An attempt was made using the second suture, however the result was the same as the first suture,wherein it broke off only this time the broken tip was located and removed from the patient.A third suture was used to complete the procedure.
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Manufacturer Narrative
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Additional information: g4, h3, h6 h3 evaluation summary: post market vigilance (pmv) received twelve devices sealed with the appropriate packaging.Visual inspection of the needles and sutures noted no abnormalities.Functionally a bend moment, single pass penetration and multiple pass penetration were performed on the needles and the results met specifications for the product.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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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