COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO DISSECT* 5MM INSTRUMENT; MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
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Model Number 176645 |
Device Problems
Failure to Align (2522); Difficult to Open or Close (2921)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/28/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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According to the reporter, during a laparoscopic cholecystectomy, prior to use on a patient during procedure, the jaw was not aligned and it did not close properly.Another device was used to continue.
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Manufacturer Narrative
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(b)(4).Post market vigilance (pmv) and engineering led an evaluation of one device.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, an engineering evaluation, and an evaluation of the returned device.The visual inspection of each device noted the jaws were misaligned.Each instrument was evaluated for electrical conductivity; proper conductivity was observed both in normal position and in roticulated position.The rotation knob functioned properly, and the jaws opened and closed grasping test media without difficulty.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.
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Search Alerts/Recalls
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