Model Number RS22 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).H6 component code: g07002 - device not returned.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.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.The following information was requested, but unavailable: was there any adverse consequence associated with the patient? did the needle fall into the patient? if yes, was the needle piece(s) retrieved during the same procedure? what tissue structure the broken needle was located? were x-rays taken to locate the needle piece(s)? what measures were taken to retrieve the broken piece? was there any additional tissue damage as a result of searching for the needle piece? does a piece of the needle remain in the patient¿s tissue? if yes, are any plans in place to remove the needle piece in future? what is the surgeon's opinion of consequences to the patient? contacted with the sales rep today via phone, please refer to the event description and other information requested is unknown.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
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Event Description
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It was reported that a patient underwent an unknown procedure on (b)(6)2023 and suture was used.During the procedure, the patient underwent surgery due to pregnancy combined with cervical incompetence.During the surgery, the needle broke.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.
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Manufacturer Narrative
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Product complaint # (b)(4).Date sent to the fda: 6/19/2023.H6 component code: g07002 no device returned.H6 component code: c22 - photo analysis.H3 photo analysis: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows two needles, one of them broken in the attached area.The image is not clear to determine the failure mode.Based on the photo review no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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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