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Model Number M00562670 |
Device Problem
Failure to Cut (2587)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2021 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during an unknown procedure performed on (b)(6) 2021.It was reported that during the procedure and inside the patient, the device would not cut.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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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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It was reported to boston scientific corporation that a sensation medium oval flexible snare was used during an unknown procedure performed on (b)(6)2021.It was reported that during the procedure and inside the patient, the device would not cut.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
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Manufacturer Narrative
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Block h6: problem code a050702 captures the reportable event of snare loop cutting problems.Block h10: investigation results a sensation medium oval flexible snare was received for analysis.Visual inspection of the returned device revealed that the working length was kinked in the distal side.Functional inspection was performed and the device contracted and extended well even with the kinked found.Electrical test was performed and the device passed, indicating a proper connection.No other problems were noted.The reported complaint of loop failure to cut could not be confirmed since the device cannot be functionally evaluated with respect to anatomical/procedural factors encountered during the procedure.Additionally, the device passed the electrical test.The product record review confirmed that this was not a new failure type and the risk was anticipated.There was no evidence of a manufacturing problem, design or user problem which could have caused the complaint.During analysis of the returned device, the working length was found to be kinked in the distal side most likely caused by the normal interaction with the scope or the anatomy.Device analysis found no problems related to the reported event.Based on the information available and the returned device analysis, the most probable root cause for the reported complaint is no problem detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
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Search Alerts/Recalls
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