Catalog Number HARH36 |
Device Problems
Hole In Material (1293); Leak/Splash (1354)
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Patient Problem
No Code Available (3191)
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Event Date 10/26/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4) date sent: 11/3/2016.No lot or batch number was provided therefore a device history could not be done.Additional information was requested and the following was obtained: were you present for the procedure? yes.How long has the surgeon been using the harmonic +7 device? first time.Long time harmonic focus user.Was the surgeon in-serviced prior to using the harmonic +7 device? yes.Did the gen11 display any yellow alert screens during the procedure? no.What technique was used with respect to the advanced hemostasis and the min/max button.Min button was the only button used.How were these features used in/around the esophageal? 3-4 activations were used on the diverticulum.How was it determined that the harh36 caused the esophageal leak/hole? unknown.What caused the hole? unknown.When was the leak noticed? the following day [the event lists the leak occurred and then the hole was repaired and then the patient being brought back to the or.Is this the correct order of events?] patient brought back to or to fix the leak.Hole noticed in esophageal tissue.
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Event Description
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It was reported that during a zenker's diverticulum procedure, the patient presented with esophageal leak posterior.Hole repaired with vicryl suture to complete the procedure.The patient was brought back to the or thirty-six hours after the initial procedure due to the esophageal leak.
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Manufacturer Narrative
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(b)(4).Additional information was requested and the following was obtained: were there any other instruments used during the initial procedure other than harh36: suture; how did the patient present with the esophageal leak: later that night following the procedure; what was the location of the hole in reference to the surgical procedure: please refer to original compliant; was there thermal damage at the site of the hole in the re-operation: the suture stated yes; does the surgeon believe that the leak was created by using the harh36: yes.
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Search Alerts/Recalls
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