BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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Model Number D2201 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that, following the priming cycle, the saline continued to flow although the needle was retracted.It was observed that the wrong scope was inserted.As the scope was removed, it was noted that the shaft disconnected from the handpiece but the silver pin was still intact.A second delivery device was used to complete the procedure without clinical consequences to the patient.
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Event Description
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It was reported that, following the priming cycle, the saline continued to flow although the needle was retracted.It was observed that the length of the scope was longer than the delivery device, the scope that was attempted to be used was the wrong scope for the delivery device.As the scope was removed, it was noted that the shaft disconnected from the handpiece but the silver pin was still intact.A second delivery device was used to complete the procedure without clinical consequences to the patient.
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Manufacturer Narrative
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Based on the available information, the root cause of the reported clinical observation cannot be established, as the product has not been returned for analysis.
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Search Alerts/Recalls
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