MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT 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 04/22/2021

Event Type  Injury  

Manufacturer Narrative

At time of filing, although expected, the reported device has not been received into conmed's complaint system 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.

Event Description

Conmed received notification via phone of reported issues with a hyfrecator 2000, item # 7-900-115, sn (b)(4) that occurred at md (b)(6) cancer center/ (b)(6) on (b)(6) 2021.It was reported only "shocked by unit".It is indicated the incident occurred during surgery and there was no impact or injury to the user or patient.Additional information received notes the doctor was using the hyfrecater to cauterize skin biopsy site.The doctor was standing next to patient on exam room floor while the patient was in exam chair.The doctor felt a mild jolt from the unit.No medical treatment was needed as a result of the issue.There were no alarms from the unit which was plugged into electrical outlet in wall, hospital grade and being used with the supplied conmed power cord.No other accessories were being used at the time.The procedure was successfully completed with no impact to the patient and no lasting impact to the doctor.This report is being raised on the basis of injury as the doctor was "shocked".

Manufacturer Narrative

The customers reported incident of the device giving off a shock is unconfirmed.An evaluation of the returned device found no fault although the preventative maintenance was overdue.The service history was reviewed and no previous service data was found.A review of the dhr found no abnormalities that would contribute to this issue.A two-year review of complaint history revealed there has been a total of 19 complaints, regarding 19 devices, for this device family and failure mode.(b)(4).As this is a reusable device, the potential number of uses is not considered in this failure rate.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the user that the power cord of the esu should be connected to a properly polarized and grounded power source whose voltage and frequency characteristics are compatible with those listed on the nameplate of this esu.To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth.This issue will continue to be monitored 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; alejandro dumas ave, 11321; complejo industrial chihuahua; chihuahua, 31136 ; MX 31136
• MDR Report Key: 11849022
• MDR Text Key: 266168093
• Report Number: 3007305485-2021-00218
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K970493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7-900-115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other