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 Problems Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event Description

The sales representative reported on behalf of the customer that the 410-2000, cga, surefit ground pad with 10ft cabel, 100/case, was stated that on an unknown date of use, the customer reported ¿massive stains/discoloration on the pad and no adhesive.¿.There was no report of injury, medical intervention, or hospitalization for the patient.It was reported that it took 5-minutes to retrieve another pad.Further assessment questioning was asked; however, to date the customer has not provided any further answers regarding how this event occurred or when.It is unknown if the pad(s) was being used during a single, surgical procedure and/or if the pad(s) was in contact with a patient at the time of discovery.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.Device not yet received.

Manufacturer Narrative

Correction: b5 has been updated to state that the failure issue was reported as "no adhesive" only since that is the reason for the filing and now lists the updated information received from the reporter that the pads were not used on a patient.H6 health effect impact updated to no pt involvement and medical device problem updated to no apparent adverse event due to updated information of not being used on patient.Manufacturer narrative: received one box of 410-2000 in unopened original packaging.Lot number was verified.There is adhesion present on the ground pads.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.There are two complaints 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 115 complaints, regarding 678 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 to inspect the pad and cable.Do not use if product is expired or apparently damaged.Check expiration date on package.After patient is in the final position, carefully remove the pad from the disposable liner by grasping the pad from the pad pull tab (located at the wire attachment end of the pad) and peeling the pad diagonally from the disposable liner.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the 410-2000, cga, surefit ground pad with 10ft cabel, 100/case, was stated that on an unknown date of use, the customer reported ¿no adhesive.¿.There was no report of injury, medical intervention, or hospitalization for the patient.It was reported that it took 5-minutes to retrieve another pad.Further assessment questioning was asked; however, to date the customer has not provided any further answers regarding how this event occurred or when.It is unknown if the pad(s) was being used during a single, surgical procedure and/or if the pad(s) was in contact with a patient at the time of discovery.Update: 29jul2022, after the filing of the initial mdr, the reporter advised that the device was never used on the patient.The reported failure was found prior to patient being in room.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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 15083256
• MDR Text Key: 302567695
• Report Number: 3007305485-2022-00109
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10653405033837
• UDI-Public: (01)10653405033837(17)230416(10)202104164
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2023
• Device Catalogue Number: 410-2000
• Device Lot Number: 202104164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic