Model Number BD-400P-1880 |
Device Problems
Difficult to Insert (1316); Difficult to Remove (1528)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The referenced device was not returned to the manufacturer for evaluation.The cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be updated and supplemented accordingly.
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Event Description
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The user facility reported that during a therapeutic and diagnostic esophagogastroduodenoscopy (egd) with dilation procedure, the physician experienced difficulty with inserting and removing the balloon from scope.It was reported that the balloon became stuck in the scope¿s channel.There was no bleeding reported.No part of the balloon fell off into the patient.The scope was withdrawn with the balloon stuck in channel and hanging out the distal tip.The balloon was removed from the scope and then reinserted to complete procedure.There was no longer stay or additional procedures needed.There was no patient injury reported.
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Manufacturer Narrative
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The device was returned to the service center for evaluation.The device arrived in a biohazard plastic bag with the distal end cut off slightly above the balloon.The luer appeared to be intact.The balloon arrived squished to towards the distal end, with the inner wiring sticking out of the proximal end of the balloon.After spacing the balloon out, it was observed that it had a large hole in it, appearing as if it burst on the proximal end of the balloon.There are also several major kinks in the middle of the sheathing on this device.The device has been shipped to the oem for further investigation.
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Manufacturer Narrative
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This supplemental report is being submitted to report additional information from the original equipment manufacturer (oem).The oem reported that the product was returned and evaluated.Unable to confirm the nonconformance.The root cause could not be identified.Nineteen similar complaints for retrieval issues have been received in the last 12 months for this part number (159-14064-xx, 159-24673-xx).Unable to confirm fourteen of these complaints as the device was not returned.Five devices were returned but the nonconformance was not confirmed.
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Manufacturer Narrative
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This supplemental report is being submitted to report additional information from the original equipment manufacturer (oem).Please see the updates in sections: g4, g7, h2, h3, h6 and h10.The dhr was reviewed for this device and no abnormalities in documentation or process were noted.
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Manufacturer Narrative
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This supplemental report is being submitted to report additional information from the original equipment manufacturer (oem).The dhr, risk management documents and historical complaint trends were reviewed, and findings documented on the complaint investigation form.The product was returned and evaluated.Unable to confirm the nonconformance.The root cause could not be identified.The oem reported that nineteen similar complaints for retrieval issues were received in the last 12 months for this part number (159-14064-xx, 159-24673-xx).Unable to confirm fourteen of these complaints as the device was not returned.Five devices were returned but the nonconformance was not confirmed.
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Search Alerts/Recalls
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