BOSTON SCIENTIFIC CORPORATION JAGTOME REVOLUTION RX; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number M00584260 |
Device Problems
Break (1069); Failure to Fold (1255); Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Event date: approximated based on the date the manufacturer became aware of the event.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem 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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Note: this report pertains to one of three jagtome revolution rx used in the same procedure.It was reported to boston scientific corporation that a jagtome revolution rx was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date was unknown.During mid procedure, when the physician bowed the device, it did not bow, and then the cutting wire of the jagtome revolution rx "busted." it was reported that the cutting wire broke, and the wire anchor dislodged from the catheter.A second and third jagtome revolution rx were used and the same thing happened.It was reported that no part of the cutting wire of the three devices detached and fell into the patient.The procedure was completed with another of the same device there were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
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Search Alerts/Recalls
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