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Model Number RNONB8STF |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/07/2021 |
Event Type
malfunction
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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, following a laboratory evaluation on a inguinal hernia procedure, a slight tear was found at the proximal seal of the port.There was no damage observed at the beginning of the evaluation when the packaging of the port that was first opened.The tear did not cause any performance issues.The port was not replaced.The port was related to the surgeon¿s right hand where the monopolar curved shears were used, likely causing the slight tear from instrument insertion and retraction.There was no patient involvement.
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Manufacturer Narrative
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Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted sharp damage on the trocar circular seal.It was reported that damage to a seal in the device.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when contact is made with a sharp surgical instrument.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: use special care when introducing or removing sharp-edged or sharp-angled endoscopic instruments to minimize the potential of inadvertent damage to the seal.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, following a laboratory evaluation on a inguinal hernia procedure, three ports were used, however a slight tear was found at the proximal seal of only one port.There was no damage observed at the beginning of the evaluation when the packaging of the port that was first opened.The tear did not cause any performance issues.The port was not replaced.The port was related to the surgeon¿s right hand where the monopolar curved shears were used, likely causing the slight tear from instrument insertion and retraction.
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Search Alerts/Recalls
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