Model Number M00545170 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2024 |
Event Type
malfunction
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Event Description
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It was reported to boston scientific corporation that an autotome rx 44 was being prepared to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During preparation, upon opening the packaging of the device, it was noticed that the cutting wire of the autotome rx 44 "was rusted and too was very faded." the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: imdrf device code a180104 captures the reportable event of presence of foreign material in the device.
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Event Description
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It was reported to boston scientific corporation that an autotome rx 44 was being prepared to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During preparation, upon opening the packaging of the device, it was noticed that the cutting wire of the autotome rx 44 "was rusted and too was very faded." the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6: imdrf device code a180104 captures the reportable event of presence of foreign material in the device.Block h10: the returned autotome rx 44 was analyzed, and a visual evaluation noted that the device had evidence of foreign material at several sections in the cutting wire lumen.No other problems with the device were noted.The reported event was confirmed.The product analysis revealed that the device has evidence of foreign material at several sections in the cutting wire lumen.Based on all gathered information, the most probable root cause of this complaint is quality control deficiency.An investigation to address this problem is in progress.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
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Search Alerts/Recalls
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