CONSOLIDATED MEDICAL EQUIPMENT COMPANY CGA, SUREFIT GROUND PAD WITH 10FT CABEL, 100/CASE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Catalog Number 410-2000 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The device is not being returned and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 78 reports, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised the following: prepare the skin at the application site according to facility protocol.If no protocol exists, clip excess hair at application site, clean and disinfect area to remove oils, lotions, etc.And allow to dry thoroughly.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 customer reported that the device, 410-2000, cga, surefit ground pad with 10ft cabel was being used on an unknown date during a polypectomy procedure and ¿while attempting to remove a colon polyp from a patient, the physician asked for cautery with polypectomy to reduce the risk of bleeding.There were 3 different conmed surefit bovie ground pads applied to the patient before the connection to the patient's skin was adequate to use the cautery function on the bovie machine.¿ there was no impact or injury to the patient.There was no report of medical/surgical intervention or prolonged hospitalization.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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