D10 concomitant product: onb15stf - onb15stf versaone opt 15mm std trocar, lot# j3g1254y nonb15stf - no blade 15mm std fix x6, lot# j3f2019y nonb15stf - no blade 15mm std fix x6, lot# j3f2019y nonb15stf - no blade 15mm std fix x6, lot# j3f2019y nonb15stf - no blade 15mm std fix x6, lot# j3f2019y nonb15stf - no blade 15mm std fix x6, lot# j3f2019y nonb15stf - no blade 15mm std fix x6, lot# j3h1177y 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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According to the reporter, during a laparoscopic procedure, when building up the pneumoperitoneum, the optical and bladeless trocars were not able to keep the pneumoperitoneum stable.Carbon dioxide (c02) escapes and blows into the surgeon's faces.Moreover, the six 15mm bladeless trocars were tried and did not keep the pneumoperitoneum stable.Another 15mm bladeless trocar with a different lot was used but also did not hold the air.It was noted that all the trocars had a damaged seal.Another trocars were used to resolve the issue.There was no patient injury.
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