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Model Number M00522612 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device problem code: (b)(4).The complainant indicated that the device has been disposed and is not available for return; 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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It was reported to boston scientific corporation that a resolution clip device was used during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, the clip grasped and locked onto tissue; however, when the tech opened the hand to separate the clip from the catheter, the clip would not separate.The physician tried twisting and shaking the scope and the tech attempted to open hand multiple times to release the clip from the catheter.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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