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Model Number M00562402 |
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 09/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(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 two devices used during the same procedure.Refer to manufacturer report # 3005099803-2021-05170 for the associated device information.It was reported to boston scientific corporation that two captiflex medium oval flexible snares were used during a colonoscopy procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, both captiflex snares were unable to cut the target polyp and had no energy.Reportedly, the generator used was an erbe endo cut.The snare was securely attached to the active cord and no visible problems were noted with the cautery pins.No other problems were noted with the devices.The procedure was completed with another captiflex snare.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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