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Model Number 174209 |
Device Problems
Difficult to Remove (1528); Retraction Problem (1536); Failure to Advance (2524); Material Twisted/Bent (2981)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/01/2020 |
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 during a laparoscopic colectomy, the slide bar came off and the metal fitting at the tip could not be taken in and out, it could not be removed from the trocar.As a small abdominal laparotomy in the colon was performed which was part of the procedure, by using the forceps, it was bent forcibly and somehow the retract part was put away, and it was able to be removed from the trocar.The procedure was completed with another device.There was no patient harm.
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Manufacturer Narrative
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Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that the handle of the instrument was received broken.It was reported that the device was difficult to remove from inside the port and was bent out of its intended shape.It was also reported that the stylet did not advance from the device and did not retract back into the device.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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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