MAUDE Adverse Event Report: MEDIVATORS INC. SCOPE BUDDY PLUS; ENDOSCOPE FLUSHING AID

Model Number	SBP-1000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow-up, it was determined that the reported event occurred the same day that in-service training and installation of the scope buddy plus endoscope flushing aid was performed.Later that day, an employee who was present at the in-service training was flushing an endoscope when the tubing slid off of the air pipe and the air water blanking cap came off of the endoscope allowing water to spray onto the employee.It was determined that the employee was not wearing proper ppe as instructed during the in-service training.Additionally, users are instructed to wear proper ppe during use of the scope buddy plus endoscope flushing aid as stated in the user manual.The scope buddy plus endoscope flushing aid user manual states, "avoid biological contamination and chemical burns.Always wear appropriate personal protective equipment (ppe) including clothing, gloves, and face shield or safety glasses when handling used endoscopes and associated chemicals." the customer was provided with a replacement unit.The technician counseled user facility personnel on the importance of wearing proper ppe while using the scope buddy plus endoscope flushing aid.The scope buddy plus endoscope flushing aid subject of the reported event will be returned for evaluation.A follow-up report 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 endoscope flushing aid, the sink water was sprayed onto the employee.No report of injury.
Additional Manufacturer Narrative
The scope buddy plus endoscope flushing aid and tubing were returned for evaluation.The scope buddy plus endoscope flushing aid was inspected and found no issues with the function or operation.The device as found to be operating according to specification.Medivators will continue to monitor for future occurrences.No additional issues have been reported.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid.

• Brand Name: SCOPE BUDDY PLUS
• Common Device Name: ENDOSCOPE FLUSHING AID
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 14605 28th ave north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 17958572
• Report Number: 2150060-2023-00044
• Device Sequence Number: 7120370
• Product Code: FEB
• UDI-Device Identifier: 00677964073755
• UDI-Public: (01)00677964073755(11)230822(21)(21)13140095
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 10/18/2023

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: SBP-1000
• Device Catalogue Number: SBP1000
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 09/21/2023; Not provided
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 02/14/2024; 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown