MAUDE Adverse Event Report: MEDIVATORS, INC. AIR/WATER BLANKING CAP FOR OLYMPUS ENDOSCOPES

Model Number SB-110-HU1017

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

The lot number of the device subject of the event is unknown.The device subject of the event was not returned to medivators for evaluation.Without a returned device, the root cause could not be determined.The a/w blanking cap 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." 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." no additional issues have been reported.

Event Description

The user facility reported that their air/water blanking cap was popping off during flushing of endoscopes and the sink water is being sprayed onto employees.No report of injury.

• Brand Name: AIR/WATER BLANKING CAP FOR OLYMPUS ENDOSCOPES
• Type of Device: AIR/WATER BLANKING CAP
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th avenue n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th avenue n; plymouth MN 55447
• Manufacturer Contact: daniel davy ; 9800 59th avenue n; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 13873776
• MDR Text Key: 289081711
• Report Number: 2150060-2022-00020
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213833
• 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: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SB-110-HU1017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1