MAUDE Adverse Event Report: MEDIVATORS INC SCOPE BUDDY PLUS TUBING

Model Number	SB-110-HU1007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Without return of the device, a root cause could not be determined.The dhr for the lot subject of the event was reviewed and no abnormalities were noted.There are no other complaints associated with this lot.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.
Event or Problem Description
The user facility reported that their scope buddy plus tubing detaches from the endoscope spraying water onto user facility personnel.No report of injury.

• Brand Name: SCOPE BUDDY PLUS TUBING
• Common Device Name: 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: 18855344
• Report Number: 1651395-2024-00011
• Device Sequence Number: 19667711
• Product Code: FEB
• UDI-Device Identifier: 00677964082924
• UDI-Public: 00677964082924
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/07/2024

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: SB-110-HU1007
• Device Catalogue Number: SB-110-HU1007
• Device Lot Number: 605203
• 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: 12/06/2023
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2023
• 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