MAUDE Adverse Event Report: MEDIVATORS INC SCOPE BUDDY PLUS TUBING

Model Number SB-110-HU1007

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 337093255
• Report Number: 1651395-2024-00011
• 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
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2023
• 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