CONSOLIDATED MEDICAL EQUIPMENT COMPANY SUREFIT DUAL FOIL WITH 15FT CORD (100/CS); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Catalog Number 410-2100 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
Skin Inflammation/ Irritation (4545)
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Event Date 03/29/2022 |
Event Type
malfunction
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Event Description
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The customer reported that the device, 410-2100, surefit dual foil with 15ft cord was being used on (b)(6) 2022 during an excision of pericardial cyst via r thoracotomy procedure and the ¿patient burned - temporary harm - spot was blanchable¿.After further assessment it was found ¿patient was placed laterally on the left side during surgery.Cautery pad was placed on right buttocks.After surgery was finished, cautery pad was taken off and a quarter sized red spot was confirmed.Spot was blanchable.On the cautery pad, there was a circle the same size as was on the patient.¿ duraprep was used for the site prep.Potential burn was quarter sized reddish/pink and blanchable per nurse in the room.There was no medical/surgical intervention required for the patient.The procedure was completed and there was no delay.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.
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Manufacturer Narrative
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Manufacturer narrative: reported event is inconclusive.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.A two-year lot history review was conducted and found a total of 2 events involving a total of 3 devices for this lot number.(b)(4).Per the instructions for use, the user is advised the following: select a well vascularized site in close proximity to the surgical site (anterior arm or thigh is recommended).Avoid placement on bony prominence, skin lesions or folds, tattoos, scars, metal prosthesis or near ecg electrodes and cables.Do not apply where fluid may pool.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, 410-2100, surefit dual foil with 15ft cord was being used on (b)(6) 2022 during an excision of pericardial cyst via r thoracotomy procedure and the ¿patient burned - temporary harm - spot was blanchable¿.After further assessment it was found ¿patient was placed laterally on the left side during surgery.Cautery pad was placed on right buttocks.After surgery was finished, cautery pad was taken off and a quarter sized red spot was confirmed.Spot was blanchable.On the cautery pad, there was a circle the same size as was on the patient.¿ duraprep was used for the site prep.Potential burn was quarter sized reddish/pink and blanchable per nurse in the room.There was no medical/surgical intervention required for the patient.The procedure was completed and there was no delay.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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