Model Number C910001 |
Device Problems
Material Protrusion/Extrusion (2979); Activation Problem (4042)
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Patient Problem
No Code Available (3191)
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Event Date 10/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device subject of the reported event was discarded by the user facility and therefore was not available for evaluation.The device history record was reviewed and confirmed the lot was manufactured to specification.There have been no other complaints associated with this lot.The instructions for use include the following statements: "carefully examine the unit to verify that neither the contents not the package have been damaged in shipment and if damaged, do not use this product and contact your local product specialist or customer service representative.Check to ensure that the scope is inserted completely into the scope mounting feature of the delivery housing and that the housing isn't expanded.Too tight of a fit can expand the scope mounting feature making the pushing mechanism sluggish and allow the padlock clip to get hung up on deployment, especially in retroflexion.Deploy the padlock clip by using a firm and rapid thrust of the thumb actuator while holding the control handle body." the distributor was onsite and immediately provided in-service training to the user facility regarding attachment of the device to the endoscope and deployment technique.No additional issues have been reported.
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Event Description
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The distributor reported the clip component was not fully deployed during use of the padlock clip defect closure system, necessitating device withdrawal with the clip prongs partially protruding from the delivery housing.Scratches were detected on the esophagus however no treatment was required.The procedure was completed with a second padlock clip defect closure system.
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Manufacturer Narrative
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Follow up filed to correct field d1 to padlock clip defect closure system.Field d1 on previous report was erroneously filled as padlock clip pro-select defect closure device.
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Search Alerts/Recalls
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