MAUDE Adverse Event Report: MEDIVATORS, INC. SCOPE BUDDY PLUS TUBING

Model Number	SB110HU1007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is currently in process.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that as an employee was flushing an endoscope with their scope buddy plus, the air connection hookup from the scope buddy plus olympus tubing "popped off" subsequently causing sink water to spray onto employees.No report of injury.
Additional Manufacturer Narrative
The tubing subject of the reported event and additional tubing from the same lot were returned for evaluation.The tubing was visually inspected, and no issues were noted.The returned tubing was further connected to an endoscope for functionality testing.During the functionality testing, the tubing performed as designed and the tubing did not pop off the air connection.The reported event was unable to be duplicated.The device history record (dhr) for the subject lot was reviewed and no issues were noted; the tubing was manufactured to specification.Steris will continue to monitor for similar events.No additional issues have been reported.

• Brand Name: SCOPE BUDDY PLUS TUBING
• Common Device Name: SCOPE BUDDY PLUS TUBING
• Manufacturer (Section D): MEDIVATORS, INC.; 3150 pollok drive; conroe TX 77303
• Manufacturer (Section G): MEDIVATORS, INC.; 3150 pollok dr; conroe TX 77303
• Manufacturer Contact: daniel davy ; 3150 pollok dr; conroe, TX 77303 ; 4403927453
• MDR Report Key: 18183915
• Report Number: 1651395-2023-00021
• Device Sequence Number: 12692034
• Product Code: FEB
• UDI-Device Identifier: 00677964082924
• UDI-Public: 00677964082924
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/21/2023

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: SB110HU1007
• Device Lot Number: 599521
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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