MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY HYFRECATOR 2000, 115V; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 7-900-115

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 09/06/2023

Event Type  malfunction  

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.H3 other text : device not yet received.

Event Description

The customer reported that the 7-900-115, hyfrecator 2000, 115v device was being used during a removal of a skin lesion procedure on (b)(6)23 when it was reported ¿hyfrecator that is shocking my physician when she uses it.It was confirmed that the patient/user was not diagnosed with a burn and ¿user received small shock¿.The procedure was completed without delay.The current status of the patient/user was reported as ¿fine¿.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

Event Description

The customer reported that the 7-900-115, hyfrecator 2000, 115v device was being used during a removal of a skin lesion procedure on (b)(6) 2023 when it was reported ¿hyfrecator that is shocking my physician when she uses it.¿.It was confirmed that the patient/user was not diagnosed with a burn and ¿user received small shock¿.The procedure was completed without delay.The current status of the patient/user was reported as ¿fine¿.There was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device was not overdue for preventative maintenance.No fault was found with the device: lfc were clear.All following specifications power accuracy and open circuit voltage meet specifications.No defects were found.Tested unit.The unit meet all specifications.The service history was reviewed, and no prior data was found.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.A two-year review of complaint history revealed there has been a total of 2 complaints, regarding 2 devices, for this device family and failure mode.During this same time frame (b)(4) 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 that safe and effective electrosurgery is dependent not only on equipment design, but also on factors under the control of the operator.It is important the instructions supplied with this equipment be read, understood and followed in order to ensure safe and effective use of the equipment.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: HYFRECATOR 2000, 115V
• 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: 17950877
• MDR Text Key: 326067609
• Report Number: 3007305485-2023-00218
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 30653405031592
• UDI-Public: (01)30653405031592(11)220627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7-900-115
• Device Lot Number: 22266260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2022
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic