MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY HOLSTER,BULK,DISP,N/STER,/250; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	130320
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The distributor reported on behalf of their customer that the 130320, holster,bulk,disp,n/ster,/250, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿doctor was using a pencil cautery suction from the (facility), and it was shocking him as he was using the cautery.The bovine pad was placed correctly.¿ there was no report of injury, medical intervention, or hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional 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 for a risk analysis could not be performed.It was discovered during the investigation that this device is only the holster for an electrode pencil and does not include the pencil device; therefore, this device alone does not have a failure mode that would match the reported scenario.Hence a risk analysis could not be performed.Clarification of the device used was requested of the reporter and no response was received.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 their customer that the 130320, holster,bulk,disp,n/ster,/250, was being used during an unknown procedure on (b)(6) 2023 reported, ¿doctor was using a pencil cautery suction from the (facility), and it was shocking him as he was using the cautery.The bovine pad was placed correctly.¿ there was no report of injury, medical intervention, or hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: HOLSTER,BULK,DISP,N/STER,/250
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 16617424
• Report Number: 3007305485-2023-00068
• Device Sequence Number: 20374595
• Product Code: GEI
• UDI-Device Identifier: 20653405002465
• UDI-Public: (01)20653405002465(11)210803(30)250(10)202108034
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K790770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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: 130320
• Device Lot Number: 202108034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic