Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY SUREFIT DUAL FOIL WITH 15FT CORD (100/CS); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONSOLIDATED MEDICAL EQUIPMENT COMPANY SUREFIT DUAL FOIL WITH 15FT CORD (100/CS); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number 410-2100
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 03/29/2022
Event Type  malfunction  
Event Description
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.
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
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.
 
Event Description
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SUREFIT DUAL FOIL WITH 15FT CORD (100/CS)
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
CONSOLIDATED MEDICAL EQUIPMENT COMPANY
ave. alejandro dumas 11321
complejo industrial chihuahua
chihuahua 31136
MX  31136
Manufacturer (Section G)
CONSOLIDATED MEDICAL EQUIPMENT COMPANY
ave. alejandro dumas 11321
complejo industrial chihuahua
chihuahua 31136
MX   31136
Manufacturer Contact
robin drum
11311 concept blvd
largo, FL 33773
8653881978
MDR Report Key14110543
MDR Text Key289275646
Report Number3007305485-2022-00047
Device Sequence Number1
Product Code GEI
UDI-Device Identifier10653405033844
UDI-Public(01)10653405033844(17)221118(10)202011185
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120322
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/18/2022
Device Catalogue Number410-2100
Device Lot Number202011185
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2020
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Age23 YR
Patient SexMale
Patient Weight116 KG
Patient EthnicityNon Hispanic
-
-