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Model Number XOM UNK BUR |
Device Problem
Intermittent Loss of Power (4016)
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Patient Problems
Eye Injury (1845); Unspecified Tissue Injury (4559)
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Event Date 11/20/2020 |
Event Type
Injury
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Manufacturer Narrative
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There were 3 devices (2 burs and 1 handpiece) being used in this surgery, we are submitting 3 mdrs for the same event.List of products involved: microdebrider 1899200 m5 rohs, serial # (b)(4), unk.Prod.Id/ drill bur unk.Prod.Id/ drill bur this is same event as regulatory report #: 1045254-2020-00634 if information is provided in the future, a supplemental report will be issued.
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Event Description
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The healthcare provider (hcp) reported that during procedure while using the hand piece in a case, it suddenly stopped drilling and the tip broke.They swapped to a quad cut tip and changed to oscillate.The new tip was working on/off then suddenly worked at full strength and removed some tissue from the eyelid and inner corner of the upper eye.
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Manufacturer Narrative
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H3: product analysis found that the inner assembly would spin freely by hand with no unusual resistance.There was no damage to the tip.When viewed under magnification, there was damage consistent with melting by another device.The information most likely indicates another device caused the reported event h6: fdm b17 and fdr c20 no longer apply.This is same event as regulatory report #: 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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