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Catalog Number MCS20 |
Device Problems
Failure to Form Staple (2579); No Apparent Adverse Event (3189)
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Patient Problems
Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date sent: 8/28/2023.D4: batch # unk.How was the bleeding controlled? by other hemostatics methods.Bipolar energy and surgicel.How much blood was lost (ml)? unknown.Did the patient require a transfusion? no.Was there any patient consequence or change in the post-operative care of the patient as a result of the event? (extended hospital stay, readmission, re-operation, etc.) unknown but i think that no.An analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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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Event Description
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It was reported that during a cardiovascular procedure, the titanium clips were dislodged from the blood vessels without being able to stop the bleeding.This lengthened the time of surgery.
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Manufacturer Narrative
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(b)(4).Date sent: 10/5/2023 d4: batch # unk additional information was requested and the following was obtained: "the incidence has been in one patient, with no complications attributable to our devices.The operating room reported this information (14 units).The client did not return the devices to report, as they had been discarded by the usual and daily security mechanism of the centre." "clinicians are satisfied with the product today.They had some incidents in the closures of the clips at some specific moments of the surgery but they were able to resolve them with other clips.They report 14 units that they had noted as small incidents and for security reasons they have escalated them to us.They don't know how to specify exactly but they insist that as of today they are calm with this device.They have been technically trained on how to correctly handle the device to avoid incomplete closure of the clips.".
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Manufacturer Narrative
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(b)(4).Date sent: 11/22/2023.Additional information was requested and the following was obtained: "1.How many procedures or patients: 1.2.How many devices failed in each procedure and how: all devices failed in the same procedure, a total of 14.The clip does not grab, it is released, so the closed vessels continues to bleed.After talking to them, everything points to a misuse of the surgeon.They have been given relevant explanations and training.".
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Search Alerts/Recalls
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