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Model Number VR917 |
Device Problems
Break (1069); Dull, Blunt (2407)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Component code: (b)(4) device not returned.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: what was the name of the procedure? what tissue was being approximated/ sutured? 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Related reports: 2210968-2022-02627, and 2210968-2022-02628.
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Event Description
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It was reported that a patient underwent an unknown surgery on (b)(6) 2022 and suture was used.During the unknown procedure it was reported that the needle tip was found blunt when sewing and the suture broke.Changed another two to continue the surgery, the same problem happened.Changed another one to complete the surgery.There were no patient consequences reported.Additional information was requested.
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Manufacturer Narrative
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Product complaint # (b)(4) date sent to the fda: 5/10/2022 additional information: d4, h4, h6 h6 component code: g07002 no device return a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: what was the name of the procedure?¿¿repair of lateral episiotomy.What tissue was being approximated/ sutured?¿¿perineal muscle layer.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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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