MAUDE Adverse Event Report: MEDIVATORS, INC. DEFENDO BIOPSY VALVE

Model Number	100315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Infections (4466)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure which included use of a defendo pentax valve kit, the biopsy valve came off and the physician was sprayed with bodily fluids in the eyes causing an eye infection.
Additional Manufacturer Narrative
Per discussion with user facility personnel, we learned that the procedure included use of a non-medivator's black wire.Facility personnel stated that it is unknown if the wire was facing down at the time of the reported event.It is possible that the black wire may have caused or contributed to the reported event.The device history record of the lot subject of the event was reviewed and no abnormalities were found.Medivators tested 10 samples of current inventory and no issues were noted.The defendo single use valve kits instructions for use (ifu) states, "warning: always wear gloves and other appropriate personal protective equipment while handling such as gown and face mask." the ifu further states, "position the single use biopsy valve onto the biopsy port of the endoscope.Always make sure the lid of the single use biopsy valve is closed.If the diameter of the accessory is >3mm, open the lid for instrumentation.".

• Brand Name: DEFENDO BIOPSY VALVE
• Common Device Name: BIOPSY VALVE
• 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: 15303567
• Report Number: 1651395-2022-00008
• Device Sequence Number: 15043103
• Product Code: ODC
• UDI-Device Identifier: 00677964055911
• UDI-Public: 00677964055911
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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): 08/26/2022

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
• Operator of Device: Health Professional
• Device Model Number: 100315
• Device Lot Number: 548765
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 08/26/2022
• Date Device Manufactured: 06/03/2022
• 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