Model Number 170056 |
Device Problems
Break (1069); Detachment Of Device Component (1104); Human-Device Interface Problem (2949)
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Patient Problems
Tissue Damage (2104); Radiation Exposure, Unintended (3164); No Code Available (3191)
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Event Date 05/29/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during a laparoscopy, the first handle used had issues with loading and unloading and was difficult to toggle.They replaced it with second handle wherein it has no issues in loading and unloading however the needle broke and fell into the cavity of the patient.A new operation and an x-ray was performed to locate, remove the broken needle and correct the issue.The hospital stay was extended, there was tissue damage reported, and incision time was extended.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.No abnormalities were found during visual inspection and functional testing of the returned product.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly or component related failures.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Needle was broken at suture swage.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly or component related failures.Replication of the bent or broken needle may occur when the needle is not loaded properly or when the needle is forced into an obstacle.This condition may also occur if excess pressure is exerted on the needle or the attached suture while the jaws are in the open position.In these situations, the needle may flex and ultimately break.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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