Model Number M00562341 |
Device Problems
Failure to Deliver Energy (1211); Failure to Cut (2587)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2022 |
Event Type
malfunction
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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 problem analysis of the complaint device, if there is any further relevant information from that review, 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 captivator medium hexagonal stiff snare was used to remove a large pedunculated polyp with stalk during an unknown procedure performed on (b)(6) 2022.It was reported that during the procedure, the snare did not cut or cauterize the target polyp.They could hear the pedal was working but electrical energy wasn't working at all.The procedure was completed with a sensation snare.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block b3: the reported event date is january 22, 2022; the event date listed in mw5108468 is february 14, 2022.Block d4: the reported lot number is 0028420760; the lot number listed in mw5108468 is 28201832.Block g2: report source (user facility) maude report mw5108468 received on april 14, 2022.Block h6: problem code a050702 captures the reportable event of snare loop cutting problems.Problem code a090402 captures the reportable event of snare unable to deliver energy.Conclusion code d17 is being used in lieu of an adequate conclusion code for "device not returned." block h10: the device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.Block h11: block b5 and g2 has been updated based on the additional information received on april 14, 2022.
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Event Description
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It was reported to boston scientific corporation that a captivator medium hexagonal stiff snare was used to remove a large pedunculated polyp with stalk during an unknown procedure performed on (b)(6) 2022.It was reported that during the procedure, the snare did not cut or cauterize the target polyp.They could hear the pedal was working but electrical energy wasn't working at all.The procedure was completed with a sensation snare.There were no patient complications reported as a result of this event.Additional information received on april 14, 2022.Erbe unit was checked in january 2022.
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Search Alerts/Recalls
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