Model Number M00584170 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Approximated based on the date the manufacturer became aware of the event.Medical device problem code a0401 captures the reportable event of cutting wire broken.Evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a device analysis 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 truetome 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date was unknown.During the procedure, the cutting wire broke when using cautery.There were no reported patient complications as a result of this event.No further information has been obtained despite good faith efforts.
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Manufacturer Narrative
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Block h2 (additional information): block b5, block d7a, block h8 have been updated based on the additional information received on august 26, 2022.Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: medical device problem code a0401 captures the reportable event of cutting wire broken.
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Event Description
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It was reported to boston scientific corporation that a truetome 44 was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date was unknown.During the procedure, the cutting wire broke when using cautery.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with the original truetome 44.There were no reported patient complications as a result of this event.
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Search Alerts/Recalls
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