MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT COMPANY UNIVERSAL PLUS-HAND CTL PISTOL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	60-6010-002
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
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
(b)(6) reported on behalf of their customer that the device, 60-6010-002, universal plus-hand ctl pistol was being used on (b)(6) 2021 during an unknown procedure when it was reported ¿suction was performed even though the suction button had not been pressed since starting use for that device.¿ the procedure was completed with an alternate unknown device.After further assessment it was found that "it occurred from the start of use out of surgical field.The device did not use for patient.¿ there was no delay to the procedure.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event is inconclusive.The device was not returned for evaluation to date and no photographic evidence was provided.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 the following: electrosurgical suction/irrigation instruments should only be used by surgeons trained in surgical endoscopy according to established hospital protocol.Improper use of this or any other electrosurgical device, can result in a patient injury.Read and become familiar with all instructions and directions before using this device.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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of their customer that the device, 60-6010-002, universal plus-hand ctl pistol was being used on (b)(6) 2021 during an unknown procedure when it was reported ¿suction was performed even though the suction button had not been pressed since starting use for that device.¿ the procedure was completed with an alternate unknown device.After further assessment it was found that "it occurred from the start of use out of surgical field.The device did not use for patient.¿ there was no delay to the procedure.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Update: customer event ¿suction was performed even though the suction button had not been pressed¿ was not confirmed during the evaluation process.Received one 60-6010-002 in opened original packaging.Lot number was verified.Performed a visual inspection, there were no obvious signs of abnormalities or defects.Performed a functional inspection, the device functioned as intended.The suction did not function unless the button was pressed.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).This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of their customer that the device, 60-6010-002, universal plus-hand ctl pistol was being used on (b)(6) 2021 during an unknown procedure when it was reported ¿suction was performed even though the suction button had not been pressed since starting use for that device.¿ the procedure was completed with an alternate unknown device.After further assessment it was found that "it occurred from the start of use out of surgical field.The device did not use for patient.¿ there was no delay to the procedure.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: UNIVERSAL PLUS-HAND CTL PISTOL
• 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: 13479872
• Report Number: 3007305485-2022-00012
• Device Sequence Number: 12099551
• Product Code: GEI
• UDI-Device Identifier: 30653405011709
• UDI-Public: (01)30653405011709(17)260614(30)1(10)202106155
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2022

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 Expiration Date: 06/14/2026
• Device Model Number: 60-6010-002
• Device Catalogue Number: 60-6010-002
• Device Lot Number: 202106155
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 03/22/2022; 05/19/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/23/2022; 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic