MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY HYFRECATOR 2000, 230V; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	7-900-230
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional 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.Device not yet received.
Event or Problem Description
The distributor reported on behalf of the customer that the 7-900-230, hyfrecator 2000, 230v during pre-operative check on (b)(6) 2023 shocked a staff member, ¿no patient plate was being used.¿.The procedure was not completed and there was no delay reported.An alternate device was not used.After further assessment it was found, "there was no injury to the doctor.There was no medical/surgical intervention required for the doctor.The doctor is ok".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
An evaluation of the returned device found broken connector plate assembly and was unacceptable to use unit.The service history was reviewed, and no 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.(b)(4).Per the instructions for use, the user is advised the following: avoid alternate site burns or potential shock, remove all metal objects from treatment area before using the hyfrecator® 2000.It is not advisable to use this instrument in the proximity of jewelry, eyeglasses, digital watches, portable radios, pocket calculators, hearing aids, etc.To minimize the possibility of shocking during monoterminal applications: do not let your patient come in contact with any grounded metal objects; position the electrode on or close to the patient before activating the output; for procedures using the dispersive plate, do not allow the patient to break contact with the dispersive plate when the unit is activated; if the physician or nurse must touch the patient, place hand on the patient before activating the hyfrecator® 2000.Do not break contact during activation.To lessen the possibility of a shock, wear gloves at all times and continue to avoid contact with grounded metal objects.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of the customer that the 7-900-230, hyfrecator 2000, 230v during pre-operative check on 27mar23 shocked a staff member, ¿no patient plate was being used.¿.The procedure was not completed and there was no delay reported.An alternate device was not used.After further assessment it was found, "there was no injury to the doctor.There was no medical/surgical intervention required for the doctor.The doctor is ok".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: HYFRECATOR 2000, 230V
• Common Device Name: 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: robin drum ; 11311 concept blvd.; largo, FL 33773 ; 8653881978
• MDR Report Key: 16751068
• Report Number: 3007305485-2023-00083
• Device Sequence Number: 8626924
• Product Code: GEI
• UDI-Device Identifier: 10653405031611
• UDI-Public: (01)10653405031611(11)180423
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K970493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 7-900-230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic