Model Number 174006 |
Device Problems
Detachment Of Device Component (1104); Physical Resistance (2578); Mechanics Altered (2984)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/16/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturer reference number: (b)(4).This event was originally reported on a quarterly summary report and is being resubmitted per fda request.
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Event Description
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According to the reporter, during a laparoscopy, the device was not firing properly.After 3 presses on the handle the clamp becomes jammed and several tacks came out at the same time.Tacks fell into the patient cavity but were retrieved.Another device was used in other to complete the case.There was no patient injury.
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Manufacturer Narrative
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Section evaluation summary: post market vigilance (pmv) led an evaluation of packaging for a device.No device was received for visual or functional analysis.Only the packaging for this unit was received in undamaged condition.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Our investigation was unable to determine a root cause or establish a relationship between the device and the reported incident.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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