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

Model Number	SB-110-HU1008
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	11/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to health canada via incident report one of the scope buddy plus tubing connections was detaching from the endoscope.No report of injury.
Additional Manufacturer Narrative
Medivators was not made aware of this event until receipt of the health canada report on (b)(6) 2022.The scope buddy plus tubing is used with the scope buddy plus endoscope flushing aid to pump fluids through endoscopes during manual cleaning.The tubing is for 24-hour use only.The device subject of the event was not returned to medivators for evaluation.The lot history record was reviewed and confirmed the lot was manufactured to specification.Medivators quality tested 10 devices from current inventory and no issues were noted.Without a returned device, a root cause could not be determined.The scope buddy plus tubing instructions for use state, "warnings & precautions inspect tubing for leaks and damage to the plastic fittings.Do not use tubing if any damage is noted." a steris account manager will offer in-service training on the proper use and operation of the scope buddy plus tubing.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility health canada report which is in accordance with our procedures and policies.No additional issues have been reported over the last 12 months since initial occurrence.

• 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: 15440860
• Report Number: 1651395-2022-00014
• Device Sequence Number: 17603466
• Product Code: FEB
• UDI-Device Identifier: 00677964082962
• UDI-Public: 00677964082962
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/16/2022

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-HU1008
• Device Lot Number: 488514
• 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: 08/17/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2021
• 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