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Model Number LT300 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Failure to Anastomose (1028); Dyspnea (1816); Pain (1994); Paresis (1998); Sepsis (2067); Vomiting (2144)
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Event Date 01/20/2023 |
Event Type
Injury
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Event Description
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It was reported that during a cholecystectomy procedure by videolaparoscopy, a procedure that occurred without complications.On the following day, patient presented with distension and abdominal pain, gases, vomiting and dyspnea, with progressive worsening in subsequent days, requiring hospitalization in the icu with a diagnostic hypothesis of abdominal sepsis.Patient submitted to laparoscopy diagnoses,4 days after first surgical procedure.Bile extravasation identified in the hepatic pedicle region, verified cystic duct with important escape of bile by detachment of the metal clip used in the previous procedure.
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Manufacturer Narrative
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(b)(4).Date sent: 7/18/2023.D4: batch # unk.The lot/ batch history records were reviewed and certified by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Search Alerts/Recalls
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