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 01/04/2024

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.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the 410-2000, cga, sure fit ground pad with 10ft cabel was being used during a colonoscopy procedure on (b)(6)2 024 when it was reported ¿our surgery department is having issues with product.They have had a few packs of these grounding pads not be very sticky compared to usual.¿.This report will be written against lot number 202202184.There was no report of injury, medical intervention, or any prolonged hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be 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.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 63 complaints, regarding 770 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 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.

Event Description

The customer reported that the 410-2000, cga, surefit ground pad with 10ft cabel was being used during a colonoscopy procedure on (b)(6) 2024 when it was reported ¿our surgery department is having issues with product.They have had a few packs of these grounding pads not be very sticky compared to usual.¿.This report will be written against lot number 202202184.There was no report of injury, medical intervention, or any prolonged hospitalization for the patient.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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 18572862
• MDR Text Key: 333620600
• Report Number: 3007305485-2024-00018
• Device Sequence Number: 1
• Product Code: GEI
• 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,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Catalogue Number: 410-2000
• Device Lot Number: 202202184
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2022
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic