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

Model Number SB110HU1007

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation of this event is currently in process.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported that as an employee was flushing an endoscope with their scope buddy plus, the air connection hookup from the scope buddy plus olympus tubing "popped off" subsequently causing sink water to spray onto employees.No report of injury.

Manufacturer Narrative

The tubing subject of the reported event and additional tubing from the same lot were returned for evaluation.The tubing was visually inspected, and no issues were noted.The returned tubing was further connected to an endoscope for functionality testing.During the functionality testing, the tubing performed as designed and the tubing did not pop off the air connection.The reported event was unable to be duplicated.The device history record (dhr) for the subject lot was reviewed and no issues were noted; the tubing was manufactured to specification.Steris will continue to monitor for similar events.No additional issues have been reported.

• Brand Name: SCOPE BUDDY PLUS TUBING
• Type of Device: 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: 18161863
• MDR Text Key: 329571554
• Report Number: 1651395-2023-00020
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964082924
• UDI-Public: 00677964082924
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SB110HU1007
• Device Lot Number: 599521
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1