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

Model Number EGA-501

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/29/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation of the reported event is in process.A follow-up report will be submitted when additional information becomes available.

Event 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.

Manufacturer Narrative

The customer was provided with a replacement unit.

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
• Type of Device: 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
• MDR Text Key: 319256123
• Report Number: 2150060-2023-00037
• Device Sequence Number: 1
• Product Code: FCX
• UDI-Device Identifier: 00677964063671
• UDI-Public: 00677964063671
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EGA-501
• Device Lot Number: 1000171085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1