Model Number 28707 |
Device Problem
Component Missing (2306)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/26/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Upon receipt at medtronic's quality laboratory, visual inspection of the returned retractor inserts and suture holder revealed two suture holders missing from the device.One loose suture holder was returned.After the device was cleaned, damage was observed to the insert near the empty space of the missing suture holder.Medtronic's investigation is in progress.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that after completion of a procedure, the customer observed that two of the suture holders from the retractor insert were missing.One was found in the garbage, but the second was not located.Fluoroscopy did not find the suture holder within the patient's body.There have been no adverse patient effects as a result of the event.
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Manufacturer Narrative
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Conclusion: after review at medtronic and its supplier, the complaint of missing suture cams was confirmed.One insert had a white mark present where the suture cam would be seated, which appeared to be a stress mark consistent with damage to the product.The returned suture cam did not appear to have any damage and would be seated in the area of the insert where the stress mark was present.The second insert did not appear to have damage and the associated suture cam was not discovered by the customer, therefore was not returned.The suggested root cause for the first insert is damage to the product, causing the suture cam to be displaced from the suture holder.For the second suture insert and cam, the root cause could not be conclusively determined.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.Medtronic will continue to monitor for future occurrences and trends.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: the customer has stated that both suture holders were attached to the retractor prior to use and that the suture holders were attached to the retractor during the procedure.Conclusion: after additional review at medtronic and its supplier it has been concluded the suture cams (holders) were not seated properly in the insert.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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