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 08/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, non-conforming 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 a break.After the case started, the first device was opened.During the case, when the surgeon was inserting the device onto the trocar tip, the tip broke off.Neither of the trocars was used on the patient, and the device was never implanted in the patient.Another device was opened and implanted.No other adverse patient effects were reported.
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Manufacturer Narrative
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Two introducers were received for evaluation.Examination of the right introducer revealed the tip to be detached and not returned.Microscopic examination of the detachment end of the right introducer revealed the detachment site to be rough and irregular, indicating stress was exerted.No abnormalities were noted with the left introducer.The information received indicated during the procedure the tip of the introducer broke off.The introducer tip may bend if it is pushed onto something hard such as bone, which indicates the introducer may not have been in the proper place to insert the anchor.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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Event Description
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According to available information, this device required replacement due to a break.After the case started, the first device was opened.During the case, when the surgeon was inserting the device onto the trocar tip, the tip broke off.Neither of the trocars was used on the patient, and the device was never implanted in the patient.Another device was opened and implanted.No other adverse patient effects were reported.
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Search Alerts/Recalls
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