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

Model 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	12/14/2022
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.This issue will continue to be monitored through the complaint system to assure patient safety.Device not yet received.
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) 2022 when it was reported, ¿immediately after the start of use, water leaked from the dial part of the electrode connection part.The surgeon thought the connection was loose, and it leaked even when the surgeon closed it again.In addition, there was an energization sound even though the (coagulation) output button was not pressed.¿.The procedure was completed with an alternative device and there was no report of patient or user impact.There was no medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event of the device leaking and making the sound of energization is unconfirmed.Received one 60-6010-003 in opened original packaging.Lot number was verified.Performed a visual inspection,the complaint cannot be confirmed.There are no obvious signs of abnormalities or defects.Performed a functional inspection using the esu system 7550(c8406),the device functions as intended and does not make any abnormal sounds or does not self-activate.The device also was functionally tested for leaking and the complaint could not be confirmed.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.(b)(4).Per the instructions for use, the user is advised: if you do not achieve proper electrosurgical effect with your normal power settings: check the ground pad for proper contact and position.Replace if necessary.Check all electrosurgical cable connections to the esu and the instrument handle.Make sure that the instrument shaft is securely locked into the instrument handle.Replace with another instrument blade if necessary.Do not attempt to repair the instrument blades or cannula in any way.If the customer is suspicious about the quality of the instrument blade or cannula following use, do not use it further and replace it with another.This issue will continue to be monitored 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 14dec22 when it was reported, ¿immediately after the start of use, water leaked from the dial part of the electrode connection part.The surgeon thought the connection was loose, and it leaked even when the surgeon closed it again.In addition, there was an energization sound even though the (coagulation) output button was not pressed.¿.The procedure was completed with an alternative device and there was no report of patient or user impact.There was no medical intervention, or hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• 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: aubrey nardozzi ; 11311 concept blvd; largo, FL 33773 ; 7273995288
• MDR Report Key: 16130833
• Report Number: 3007305485-2023-00006
• Device Sequence Number: 7524082
• Product Code: GCJ
• UDI-Device Identifier: 30653405011723
• UDI-Public: (01)30653405011723(17)270220(10)202202215
• 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
• Report Date (Section B): 02/21/2023

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 Model Number: 60-6010-003
• Device Catalogue Number: 60-6010-003
• Device Lot Number: 202202215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic