ETHICON ENDO-SURGERY, LLC. HARMONIC HD 1000I SHEARS 36CM SHAFT; INSTRUMENT, ULTRASONIC SURGICAL
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Catalog Number HARHD36 |
Device Problem
Device Slipped (1584)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # p93a9t.Investigation summary: the device was returned with the tissue pad damaged, melted, and 100% present.The device was connected to a gen11 and the device did activate during functional testing.When device was disassembled to inspect the internal components, no anomalies were found related to the reported event.However, what was found was that there was a cracked internal component; the y-link.Probable causes of tissue pad damage are applying pressure between the instrument blade and tissue pad without having tissue between them.Keep the clamp arm open when back cutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad.The batch history record was reviewed and there were no defects, protocols or ncr(s) found during the manufacturing process related to this complaint.
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Event Description
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It was reported that during a laparoscopic right colectomy procedure, the device was used, but at the beginning of the surgery (15 minutes) it presented the following defect, the tissue pad began to come loose from the mandible.Then the surgeon requested to change the clamp.After the replacement, he was able to perform the procedure normally.Patient consequence was not reported.
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