BOSTON SCIENTIFIC CORPORATION RX NEEDLE KNIFE XL; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number M00545840 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2022 |
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.(b)(4).
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Event Description
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Note: this report pertains to the third of three rx needle knife xl used in the same procedure.It was reported to boston scientific corporation that an rx needle knife xl was used in the duodenum in front of the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date was unknown.During the procedure, when the handle was actuated, it was observed that the physician could not extend the needle as the device had no needle.Afterwards, it was noticed that the pull wire in the handle was broken.A second rx needle knife xl was used; however, there was no needle when the handle was actuated and the pull wire in the handle was broken.A third rx needle knife xl was used and was also reported to be "broken".The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: a photo of the second complaint device outside the patient was provided by the customer and shows the pull wire in the handle was broken and kinked.
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Manufacturer Narrative
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Block b3: approximated based on the date the manufacturer became aware of the event.Block h6 (device codes): medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned rx needle knife xl was analyzed, and a visual evaluation noted that the working length was free from obvious kinks/bends.A functional inspection was performed by extending and retracting the handle, and the needle (cutting wire) extended and retracted as intended.The device was observed under magnification, and the needle was in good condition and there was no visual damage noted.No problems with the device were noted.The reported event of broken pull wire in the handle was not confirmed.Upon analysis, the device did not have any visual damage.The device also extended and retracted fully as intended during functional inspection, indicating that the wire was not broken.The returned unit did not show evidence of either the alleged problem(s) or any defect which could have contributed to the event.Based on all gathered information, the complaint will be documented as "no problem detected." a labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
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Event Description
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Note: this report pertains to the third of three rx needle knife xl used in the same procedure.It was reported to boston scientific corporation that an rx needle knife xl was used in the duodenum in front of the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date was unknown.During the procedure, when the handle was actuated, it was observed that the physician could not extend the needle as the device had no needle.Afterwards, it was noticed that the pull wire in the handle was broken.A second rx needle knife xl was used; however, there was no needle when the handle was actuated and the pull wire in the handle was broken.A third rx needle knife xl was used and was also reported to be "broken".The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: a photo of the second complaint device outside the patient was provided by the customer and shows the pull wire in the handle was broken and kinked.
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