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Model Number 8886848813 |
Device Problems
Device Slipped (1584); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/06/2023 |
Event Type
malfunction
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Event Description
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According to the reporter, during a laparoscopic cholecystectomy due to gallstones with acute attach of chronic cholecystitis, during surgery, the cystic duct was ligated with two absorbable clips.Two days after, the patient developed a mid-upper abdominal pain with bile-fluid drained from the drainage tube, and ct scan examination revealed peritoneal effusion.On the evening of the same day, another emergency laparoscopic exploratory examination was performed.During the surgery, the two absorbable ligation clips used to ligate the cystic duct completely fell off, and the cystic duct was re-ligated with plastic clips.The absorbable ligation clip fell off because it was not completely clipped during the clipping process.The patient was hospitalized for three days longer.The ascites was not caused by the absorbable ligature clips.
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Manufacturer Narrative
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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 have not 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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