COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
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Catalog Number 519650 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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Event Description
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According to available information, this device required replacement due to detachment.The static anchor to the device broke.No other adverse patient effects were reported.
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Event Description
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According to available information, this device required replacement due to detachment.The static anchor to the device broke.No other adverse patient effects were reported.
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Manufacturer Narrative
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An altis sling was received for examination.Examination of the sling revealed the static anchor detached from the mesh and not received.Microscopic examination of the static suture where the static anchor had detached revealed rough and irregular surfaces, indicating stress may have been exerted.The dynamic anchor and tensioner were received, and the dynamic suture was still attached.Blood residue was noted on the mesh.The information received indicated the static anchor detached during implant.Quality confirmed the detached static anchor.As the static anchor was not received, it was concluded that the detachment of the dynamic suture most likely occurred during the tensioning part of the procedure.As the detachment ends of the static suture were rough and irregular, this indicated that excess stress most likely exerted to result in the separation noted.A review of the device history record by the contract manufacturer confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.
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Search Alerts/Recalls
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