BOSTON SCIENTIFIC CORPORATION HABIB ENDOHPB; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number M00500070 |
Device Problems
Failure to Deliver Energy (1211); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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It was reported to boston scientific corporation that a habib endohpb catheter was used to treat precancerous ampulla burn during a radiofrequency ablation (rfa) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when the foot peddle was pushed down to deliver energy there was no evidence of blanching at the ampulla/polyp where there was contact.The procedure was rescheduled due to this event because the physician did not have another habib endohpb catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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Search Alerts/Recalls
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