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

Model Number	60-6010-005
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
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.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 60-6010-005, universal plus straight-rocker was being used during a general surgery procedure on (b)(6) 2022 and ¿saline leaking around the connection between the irrigator and the bovie spatula.Also, the bovie was firing off when the button was not being depressed.¿ there was no report of medical intervention or any prolonged hospitalization for the patient.The procedure was completed with an alternate same device and there was no delay.After further assessment it was found there was no impact or injury to the patient or user.The 60-5272-032, lap elect,removable,32,spatula will be listed as a concomitant device.There was no allegation against the 60-5272-032, lap elect,removable,32,spatula.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 for evaluation and no photographic evidence was provided therefore the reported event could not 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 revealed there has been a total of 10 reports, regarding 10 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).This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
Update: per assessment received on 7jun22 the procedure was a gyn.No injury, delay, extended hospitalization or medical/surgical intervention was needed per dr.The sales representative reported on behalf of the customer that the device, 60-6010-005, universal plus straight-rocker was being used during a general surgery procedure on 13may22 and ¿saline leaking around the connection between the irrigator and the bovie spatula.Also, the bovie was firing off when the button was not being depressed.¿ there was no report of medical intervention or any prolonged hospitalization for the patient.The procedure was completed with an alternate same device and there was no delay.After further assessment it was found there was no impact or injury to the patient or user.The 60-5272-032, lap elect,removable,32,spatula will be listed as a concomitant device.There was no allegation against the 60-5272-032, lap elect,removable,32,spatula.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: UNIVERSAL PLUS STRAIGHT-ROCKER
• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 14596214
• Report Number: 3007305485-2022-00072
• Device Sequence Number: 16704060
• Product Code: GCJ
• UDI-Device Identifier: 30653405011730
• UDI-Public: (01)30653405011730(17)240118(10)202201184
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K954056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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: 01/18/2024
• Device Model Number: 60-6010-005
• Device Catalogue Number: 60-6010-005
• Device Lot Number: 202201184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 60-5272-032, LAP ELECT
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic