BOSTON SCIENTIFIC CORPORATION HYDRATOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number M00583040 |
Device Problems
Break (1069); Failure to Fold (1255)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/26/2022 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a hydratome rx 44 was used in the biliary sphincter during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(4) 2022.During the procedure, the cutting wire bowed; however, it was in a tough position and it did not respond like the physician expected.After multiple attempts of bowing the device completely, the pull wire from the handle broke.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Search Alerts/Recalls
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