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Model Number M00522610 |
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 03/02/2022 |
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 resolution clip device was used in the intestine during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Block h6: medical device problem code a15 captures the reportable event of clip unable to release from the catheter.Block h10: investigation results the returned resolution clip device was analyzed, and a visual evaluation noted that the device was returned with the clip assembly attached and with the clip arms opened.Microscopic examination was performed and it was found that the control wire was disconnected from the spool.Additionally, it looks like that the control wire was not correctly inserted into the cross pin.Functional evaluation found that there was no communication between the handle and the clip assembly.No other problems with the device were noted.Based on the condition of the returned device, the reported event of clip unable to release from the catheter was not confirmed.It is possible that the found problem of control wire disconnected from the handle could have caused the handle to lose communication from the clip assembly, resulting to the control wire got separated from the handle.This action could also have caused that the physician was unable to perform the first activation, preventing the clip arms to close.Additionally, it looks like that the control wire was not correctly inserted into the cross pin.Therefore, the most probable root cause of this event is manufacturing deficiency as the reported event was traced to the manufacturing process.An investigation to address this problem is in progress.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
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Event Description
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It was reported to boston scientific corporation that a resolution clip device was used in the intestine during a colonoscopy procedure performed on (b)(6) 2022.During the procedure, the clip was able to grasp and lock onto tissue; however, the clip was unable to release from the catheter to deploy.The procedure was completed with another resolution clip device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
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Search Alerts/Recalls
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