Model Number DIS150 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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The sales representative reported on behalf of the customer that the device, dis150, disposable marked spring tip guidewire was being used on an unknown date during an unknown procedure and the guidewire bent.There was no impact or injury to the patient or user.There was no report of medical/surgical intervention or prolonged hospitalization for the patient.No other information is known.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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Manufacturer Narrative
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The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet received.
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Manufacturer Narrative
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Received one dis150 in opened original packaging.Lot number was verified.Performed a visual inspection, the complaint has been confirmed.The guidewire is bent at the spring tip.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.A two-year lot history review was conducted and found no similar events reported for this failure for this lot number.A two-year review of complaint history revealed there has been a total of 25 reports, regarding 51 devices, for this device family and failure mode.During this same time frame 50,870 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.001.Per the instructions for use, the user is advised the following: the guidewire should not be advanced if resistance is met without determining the cause and taking remedial action.Carefully inspect the unit to verify that the sterile package of the product has not been damaged in shipment.Remove the guidewire from packaging and remove the tape attached to wire.Carefully inspect it for any damage that may have occurred during transit or handling.Guidewire is inserted through the biopsy channel of an endoscope with the spring tip to be located just past the esophogastric (e.G.) junction into the gastric cavity.The endoscope is then withdrawn.The guidewire should be monitored externally using markings as dental arch reference points before and during dilatation.This issue will continue to be monitored through the complaint system to assure patient safety.
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Event Description
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The sales representative reported on behalf of the customer that the device, dis150, disposable marked spring tip guidewire was being used on an unknown date during an unknown procedure and the guidewire bent.There was no impact or injury to the patient or user.There was no report of medical/surgical intervention or prolonged hospitalization for the patient.No other information is known.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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Search Alerts/Recalls
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