MAUDE Adverse Event Report: MEDIVATORS INC YOKE DUAL FOR CO2 TANK TO ENDOSTRATUS CO2 INSUFFLATOR

Model Number	EGA-501
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that the yoke dual valve for their co2 tank that attaches to their endostatus co2 insufflator was not operating properly resulting in procedure delays.No report of injury.
Additional Manufacturer Narrative
The customer was provided with a replacement unit.
Additional Manufacturer Narrative
The endostratus dual yoke was not returned to steris for evaluation.Without the returned device, a root cause could not be determined.A three-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: YOKE DUAL FOR CO2 TANK TO ENDOSTRATUS CO2 INSUFFLATOR
• Common Device Name: YOKE DUAL FOR CO2 TANK TO ENDOSTRATUS CO2 INSUFFLATOR
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 14605 28th ave north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 17325840
• Report Number: 2150060-2023-00037
• Device Sequence Number: 5641977
• Product Code: FCX
• UDI-Device Identifier: 00677964063671
• UDI-Public: 00677964063671
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2023

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: EGA-501
• Device Lot Number: 1000171085
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 06/15/2023; 06/15/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/18/2023; 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown