MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. AQUASHIELD WATER BOTTLE SYSTEM

Model Number	00711540
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their aquashield water bottle system did not perform properly resulting in a procedure delay.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event has not been returned to steris endoscopy for evaluation.The device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.Statements from the instructions for use packet include, "prime the air/water channel prior to insertion of the endoscope into a patient.If water pressure is low, check to see that the lid cap is tightly closed, and the endoscope connector is firmly attached tothe air/water port connection.If water bottle needs to be replaced, use proper aseptic technique." a steris product specialist provided in-service training on the proper set-up of the aquashield water bottle system.No additional issues have been reported.

• Brand Name: AQUASHIELD WATER BOTTLE SYSTEM
• Common Device Name: AQUASHIELD WATER BOTTLE SYSTEM
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 15293504
• Report Number: 1528319-2022-00041
• Device Sequence Number: 2805911
• Product Code: FEQ
• UDI-Device Identifier: 00724995183813
• UDI-Public: 00724995183813
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 00711540
• Device Catalogue Number: 00711540
• Device Lot Number: 2200341
• 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: 07/26/2022
• Initial Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown