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Catalog Number MB-35-2X4-8 |
Device Problems
Difficult to Fold, Unfold or Collapse (1254); Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown but it occurred during the week of (b)(6) 2020.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report and determined the handle was disconnected from the drive wire.The device was returned with the basket fully retracted and a clear liquid inside of the tubing.The handle was manipulated and no movement was noted with the basket.The handle was disassembled and it was noted that the drive wire was disconnected from the handle with nesting inside the purple hub.For further evaluation of the drive wire cable and basket, the catheter was cut to push the drive wire cable out of the sheath.The basket was fully formed and intact, and evidence of solder was present on the handle cannula at the joint.An unknown yellow substance was observed on the basket and drive wire.An unknown red substance was also observed on the distal end of the tubing.No other anomalies were detected with the devices.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: the report of unable to open the basket was due to a separation of the device in the handle.The cause of the separation is unknown.The instructions for use indicates: "advance device through channel, in short increments, until basket sheath exits endoscope." the instructions for use also states: "confirm desired position of basket sheath relative to target.Advance basket out of sheath.Caution: pulling on sheath while advancing or retracting basket may damage device, rendering it inoperable." basket deployment difficulties and buckling/breaking of the drive wire can occur if the device experiences excessive pressure.Resistance in basket movement and bends in the catheter can occur if the elevator of the endoscope is used to deflect the device at a sharp angle.Prior to distribution, all memory ii double lumen extraction baskets are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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Event Description
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During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a memory ii double lumen extraction basket.The memory ii double lumen extraction basket was delivered to the common bile duct and the user tried to open the basket but the handle did not open at all.Another memory ii double lumen extraction basket was used instead.The device was evaluated on 22-september-2020 which determined that the drive wire separated from the handle [subject of report].A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the basket fully retracted and a clear liquid inside of the tubing.The handle was manipulated and no movement was noted with the basket.The handle was disassembled and it was noted that the drive wire was disconnected from the handle with nesting inside the purple hub.For further evaluation of the drive wire cable and basket, the catheter was cut to push the drive wire cable out of the sheath.The basket was fully formed and intact, and evidence of solder was present on the handle cannula at the joint.An unknown yellow substance was observed on the basket and drive wire.An unknown red substance was also observed on the distal end of the tubing.No other anomalies were detected with the devices.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: the report of unable to open the basket was due to a separation of the device in the handle.The cause of the separation is unknown.The instructions for use indicates: "advance device through channel, in short increments, until basket sheath exits endoscope." the instructions for use also states: "confirm desired position of basket sheath relative to target.Advance basket out of sheath.Caution: pulling on sheath while advancing or retracting basket may damage device, rendering it inoperable." basket deployment difficulties and buckling/breaking of the drive wire can occur if the device experiences excessive pressure.Resistance in basket movement and bends in the catheter can occur if the elevator of the endoscope is used to deflect the device at a sharp angle.Prior to distribution, all memory ii double lumen extraction baskets are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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Event Description
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During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a memory ii double lumen extraction basket.The memory ii double lumen extraction basket was delivered to the common bile duct and the user tried to open the basket but the handle did not open at all.Another memory ii double lumen extraction basket was used instead.The device was evaluated on (b)(6) 2020 which determined that the drive wire separated from the handle clarification was received on 15-october-2020 that stated that this incident was associated with an unknown lot number [reason for correction report].A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Search Alerts/Recalls
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