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

Model Number	SB-110-HU1007
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the scope buddy plus tubing disconnected from their scope buddy plus endoscope flushing aid subsequently causing water to contact the wall outlet in which the device was plugged into.User facility personnel observed a "spark" from the wall outlet and unplugged the device.No report of injury.
Additional Manufacturer Narrative
Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
Steris made multiple attempts to obtain the device subject of the reported event for evaluation however, the device was not returned.Without the return or evaluation of the device, the cause of the event cannot be determined.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 drive; conroe TX 77303
• Manufacturer Contact: daniel davy ; 3150 pollok dr; conroe, TX 77303
• MDR Report Key: 22152309
• Report Number: 1651395-2025-00014
• Device Sequence Number: 15530877
• Product Code: FEB
• UDI-Device Identifier: 00677964082924
• UDI-Public: (01)00677964082924(11)250411(10)657726
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K213833
• 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): 06/05/2025

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: SB-110-HU1007
• Device Catalogue Number: SB110HU1007
• Device Lot Number: (10)657726
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2025
• 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