MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY UNIVERSAL PLUS STRAIGHT-BUTTON; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	60-6010-003
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, 60-6010-003, universal plus straight-button, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿it was reported that the device had unintended outputs during the surgery.A defective output button is suspected.¿.There was no initial report of injury, medical intervention, or hospitalization for the patient or user.Further questioning was sent to the reporter to clarify if self-activation is being reported; however, we have not received an answer to date.The 60-5274-032, spatula electrod w/stealth er 5mm x 32cm (5/cs), will be listed as the concomitant device that was used.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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.
Additional Manufacturer Narrative
Received one 60-6010-003 in opened original packaging.Lot number was verified.Performed a visual inspection, there were no obvious signs of abnormalities or defects on the handpiece however, there is water damage/ corrosion on the plug.Performed a functional inspection using the esu system 7550 (c8406), the device functioned as intended when the buttons were pressed.The device does not activate on its own.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 revealed there has been a total of 20 complaints, regarding 20 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).Per the instructions for use, the user is advised that when not in use, electrosurgical instruments should be placed in a suitable holder or site which will prevent current flow to the patient, should the operator accidentally activate the electrosurgical generator.Do not use these or any electrosurgical instruments with a cable that does not make good, secure contact with the electrosurgical generator.If in doubt about the compatibility of a cable from another manufacturer, use the cable provided with this instrument or consult your hospital biomedical engineer.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, 60-6010-003, universal plus straight-button, was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿it was reported that the device had unintended outputs during the surgery.A defective output button is suspected.¿.There was no initial report of injury, medical intervention, or hospitalization for the patient or user.Further questioning was sent to the reporter to clarify if self-activation is being reported; however, we have not received an answer to date.The 60-5274-032, spatula electrod w/stealth er 5mm x 32cm (5/cs), will be listed as the concomitant device that was used.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.Update: on (b)(6) 2023, reporter states, "both devices beeped when those were not used.".
Additional Manufacturer Narrative
Correction: qty (b)(4) 60-6010-003 were received, same lot, same reported failure and same evaluation statement.Evaluation statement updated below.Manufacturer narrative: received one 60-6010-003 in opened original packaging and a second device with unoriginal packaging.Lot number was verified for one device.Performed a visual inspection, there were no obvious signs of abnormalities or defects on the handpiece.There is water damage/ corrosion on the plug.Performed a functional inspection using the esu system 7550 (c8406), the devices functioned as intended when the buttons were pressed.The devices do not activate on its own.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 revealed there has been a total of (b)(4) complaints, regarding 21 devices, for this device family and failure mode.During this same time frame (b)(4) devices 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 when not in use, electrosurgical instruments should be placed in a suitable holder or site which will prevent current flow to the patient, should the operator accidentally activate the electrosurgical generator.Do not use these or any electrosurgical instruments with a cable that does not make good, secure contact with the electrosurgical generator.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, 60-6010-003, universal plus straight-button, qty (b)(4), was being used during an unknown procedure on (b)(6) 2023 when it was reported, ¿it was reported that the device had unintended outputs during the surgery.A defective output button is suspected.¿.There was no initial report of injury, medical intervention, or hospitalization for the patient or user.Further questioning was sent to the reporter to clarify if self-activation is being reported; however, we have not received an answer to date.The 60-5274-032, spatula electrod w/stealth er 5mm x 32cm (5/cs), qty(b)(4), will be listed as the concomitant device that was used.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.Update: 14sep23, reporter states, "both devices beeped when those were not used.".

• Brand Name: UNIVERSAL PLUS STRAIGHT-BUTTON
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 17508417
• Report Number: 3007305485-2023-00183
• Device Sequence Number: 17701106
• Product Code: GCJ
• UDI-Device Identifier: 30653405011723
• UDI-Public: (01)30653405011723(17)270317(10)202203185
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2023

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: 60-6010-003
• Device Lot Number: 202203185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 08/29/2023; 11/20/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/20/2023; 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 60-5274-032, SPATULA ELECTROD; 60-5274-032, SPATULA ELECTROD; 60-5274-032, SPATULA ELECTROD
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic