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)
Date of Event	09/06/2024
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.The scope buddy plus tubing instructions for use state, "warnings & precautions inspect tubing for leaks and damage to the plastic fittings.Do 1651395-2024 not use tubing if any damage is noted." users are instructed to wear proper ppe during use of the scope buddy in the user manual.The scope buddy endoscope flushing aid user manual states, "operator safety 2.Avoid biological contamination and chemical burns.Always wear appropriate personal protective equipment (ppe) including clothing, gloves, and safety glasses when handling used endoscopes." a steris account manager will offer in-service training on the proper use and operation of the scope buddy tubing.No additional issues have been reported.
Event or Problem Description
The user facility reported that their scope buddy plus tubing detached from the endoscope spraying water onto user facility personnel.No report of injury.
Additional Manufacturer Narrative
The steris territory manager conducted in-service training on the proper use and operation of the scope buddy tubing.There have been no other complaints associated with this lot.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: 20376832
• Report Number: 1651395-2024-00020
• Device Sequence Number: 14389019
• Product Code: FEB
• UDI-Device Identifier: 00677964082924
• UDI-Public: (01)00677964082924(11)20240510(10)626935
• 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): 10/04/2024

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: SB110HU1007
• Device Lot Number: (10)626935,(10)632229
• 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: 09/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2024
• 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