Model Number 72203012 |
Device Problems
Suction Problem (2170); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: 72203012 - dense tis shaver plus 72203012 truclear, lot# 5350622.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 myomectomy, inside of the uterine cavity, the uterine cavity could not be distended.Each time the surgeon went to activate the blade, it would lose visualization due to the loss of suction at the tip of the blade.The blade was window-locked, but was still leaking suction from the distal tip.To complete the procedure another device was used.The surgeon would only lose distension in the cavity when the blade was inserted and turned on the suction lever to the handpiece shaver.The blade is supposed to ¿window lock¿ when the black line in the internal cannula is lined up within the black ¿v¿ of the external cannula.When the device was removed, the suction was leaking, and therefore knew it was not window locking correctly.Two different blades were tried from the same lot number and both blades were creating the same issue.There was 1.5 hours extended time.There was no patient injury.
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Search Alerts/Recalls
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