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Catalog Number 9560702 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Burn(s) (1757)
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Event Date 02/08/2019 |
Event Type
Injury
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Manufacturer Narrative
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Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Although it is unknown if the device caused or contributed to the reported event or not, we are filing this report for notification purposes.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that intra-op, heat burn to patient's back where connection of light source to light cord attaches.Radiance light source used with size 20 tubes.The protective covering was not slid over the light source to light cord connection.After first tlif was complete, burns were noticed on the patients back and identified to be caused by the light source/light cord connection.A vaseline gauze was immediately placed on the burn, and the covering slid over the light source to light cable connection.
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Manufacturer Narrative
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Additional information: d10, h3, h6 h6: product analysis results: there does not appear to be a problem with the light source.Per the reported event the cover was not pulled over the connector.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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