BOSTON SCIENTIFIC - COSTA RICA (COYOL) TRUETOME¿ JAG 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number M00583100 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4).According to the complainant, the suspect device was contaminated and is not available for return.If any further relevant information is received, a supplement mdr will be filed.
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Event Description
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It was reported to boston scientific corporation that a truetome¿ jag 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the nurse tried to pull the device handle in order the bow the truetome¿ jag 44 and cut the papilla.At this time, it was noticed that the cutting wire dislodged from the catheter.The procedure was completed with a different device.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 stable.
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