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 Date 03/08/2023 |
Event Type
malfunction
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Event Description
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The sales representative reported on behalf of the customer that the 410-2000, cga, surefit ground pad with 10ft cabel, 100/case was used during an unknown procedure around the date of (b)(6) 2023, when it was reported, ¿complaints of surefit grounding pads not sticking.Requesting to send them back and replace with two boxes of our next surfeit pads¿.After further assessment, it was reported,¿ to my understanding the complaint was just that the pads are not sticking as well as competitor pads.No patient was hurt/ affected besides staff having to re-stick the pad to the patient multiple times in several different cases.¿ after several requests to gain more information about the other incidents, a good faith effort was completed; however, the reporter has not responded to our attempts for further information.There was no patient or user injury, prolonged hospitalization, or medical intervention.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.We will continue to monitor for trends through the complaint system to assure patient safety.
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Manufacturer Narrative
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The device has not been returned to date and no photographic evidence has been provided; therefore, the reported event 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 44 complaints, regarding 234 devices, for this device family and failure mode.During this same time frame 13,823,780 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 0.00002.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.Do not open package until ready to apply pad to skin.Inspect the pad and cable.Do not use if product is expired or apparently damaged.Check expiration date on package.We will continue to monitor for trends 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 410-2000, cga, surefit ground pad with 10ft cabel, 100/case was used during an unknown procedure around the date of (b)(6) 2023, when it was reported, ¿complaints of surefit grounding pads not sticking.Requesting to send them back and replace with two boxes of our next surfeit pads¿.After further assessment, it was reported,¿ to my understanding the complaint was just that the pads are not sticking as well as competitor pads.No patient was hurt/ affected besides staff having to re-stick the pad to the patient multiple times in several different cases.¿ after several requests to gain more information about the other incidents, a good faith effort was completed; however, the reporter has not responded to our attempts for further information.There was no patient or user injury, prolonged hospitalization, or medical intervention.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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