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  

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 202306224.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 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.

• 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: 18571932
• MDR Text Key: 333612941
• Report Number: 3007305485-2024-00017
• 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 Catalogue Number: 410-2000
• Device Lot Number: 202306224
• 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: 06/22/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic