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 Type  malfunction  

Event Description

The sales representative reported on behalf of the customer that the 410-2000, cga, surefit ground pad with 10ft cable, 100/case was used during an unknown procedure around the approximate 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 regarding this 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.

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.We will continue to monitor for trends through the complaint system to assure patient safety.Other text : have not received device as of yet.

Manufacturer Narrative

Correction: the date of the procedure is not known; therefore, b5 has been updated with this information.Manufacturer narrative: the device were returned to the distribution center in error and scrapped without performing an evaluation.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.(b)(4).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 h3 other text: device scrapped by return to wrong conmed location.

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 used during an unknown procedure on an unknown date, 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 regarding this 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.

• 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: 16666085
• MDR Text Key: 312689798
• Report Number: 3007305485-2023-00071
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10653405033837
• UDI-Public: (01)10653405033837(17)240530(10)202205315
• 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: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 410-2000
• Device Lot Number: 202205315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2022
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic