ETHICON ENDO-SURGERY, LLC. ENSEAL 45 CM SHAFT, CURVED JAW; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
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Model Number NSLX145C |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Failure to Anastomose (1028); Abdominal Pain (1685); Nausea (1970); Confusion/ Disorientation (2553); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/31/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Batch #: unknown.(b)(4).An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If the product or additional information is received at a later date, the investigation will be updated as applicable.
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Event Description
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It was reported that during/after a gastro-intestinal procedure clinical trial that the patient experienced nausea, confusion, abdominal pain, ileus, and anastomotic leak.
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Manufacturer Narrative
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(b)(4).Date sent: 9/2/2021.Additional information was requested and the following was obtained: adverse event term: abdominal pain; outcome: "recovered/resolved;" severity value: "moderate;" relationship to study device: not related; relationship to primary study procedure: not related.Adverse event term: nausea; outcome: "recovered/resolved;" severity value: "moderate;" relationship to study device: "not related;" relationship to primary study procedure: "causal relationship." adverse event term: ileus; outcome: "recovered/resolved;" severity: "moderate;" relationship to study device: "not related;" relationship to primary study procedure: "causal relationship." adverse event term: anastomotic leak; severity: severe; outcome: ¿recovered/resolved;" relationship to study device: not related; relationship to primary study procedure: not related.Adverse event term: confusion; severity: mild; outcome: recovered/resolved; relationship to study device: not related.Relationship to primary study procedure: causal relationship upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.
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Search Alerts/Recalls
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