MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY CGA, SUREFIT GROUND PAD WITH 10FT CABEL, 100/CASE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 410-2000

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of their customer that the device 410-2000, cga, surefit ground pad with 10ft cabel, 100/case,was being used during a right total hip arthroplasty on (b)(6) 2022 when it was reported that the ¿during the positioning phase of a total hip replacement, the surgeon went to attach a cautery pad to the patient's calf.A conmed surefit cautery pad was attempted for use but the team all felt the pad was not sticky at all and wasn¿t adhering to the patient's calf.A second one was opened and was also not very sticky.The circulating nurse delayed positioning by massaging the pad on the calf for over a minute until the machine showed the pad was good for use.Surgeon would like to use an alternative.¿ further assessment found there was minutes of delay to the surgery.There was no apparent harm to the patient and the medical intervention was massaging the pad on the calf which allowed for the procedure to be completed.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

To date, the device has not been returned for evaluation and no photographic evidence has been provided.Therefore, the reported failure could not 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 33 complaints, regarding 197 devices, for this device family and failure mode.During this same time frame 10,232,460 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 to 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.

Event Description

The sales representative reported on behalf of their customer that the device 410-2000, cga, surefit ground pad with 10ft cabel, 100/case,was being used during a right total hip arthroplasty on 5july22 when it was reported that the ¿during the positioning phase of a total hip replacement, the surgeon went to attach a cautery pad to the patient's calf.A conmed surefit cautery pad was attempted for use but the team all felt the pad was not sticky at all and wasn¿t adhering to the patient's calf.A second one was opened and was also not very sticky.The circulating nurse delayed positioning by massaging the pad on the calf for over a minute until the machine showed the pad was good for use.Surgeon would like to use an alternative.¿ further assessment found there was minutes of delay to the surgery.There was no apparent harm to the patient and the medical intervention was massaging the pad on the calf which allowed for the procedure to be completed.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: CGA, SUREFIT GROUND PAD WITH 10FT CABEL, 100/CASE
• 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: courtney pomichter ; 525 french rd; utica, NY 13502 ; 3156243170
• MDR Report Key: 15032638
• MDR Text Key: 300558069
• Report Number: 3007305485-2022-00101
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10653405033837
• UDI-Public: (01)10653405033837(17)230217(10)202102175
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2023
• Device Catalogue Number: 410-2000
• Device Lot Number: 202102175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic