MAUDE Adverse Event Report: MEDIVATORS, INC. DEFENDO OLYMPUS SINGLE USE VALVE KIT; DEFENDO - OLYMPUS VALVE KIT

Model Number	100322
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was not returned for evaluation.Without the return of the device, a root cause can not be determined.The device review history (dhr) for the subject lot was reviewed, and no abnormalities were found.A complaint review was conducted for this lot and indicates this to be an isolated event.A steris product specialist confirmed that user facility personnel were over-tightening the irrigation adaptor subsequently causing the threading to tear and the reported leaking to occur.The instructions for use states, "attach the single use endogator connector to the gi endoscope's auxiliary water port by engaging the threads and turning slowly until you feel resistance." the steris product specialist performed in-service training on the proper use and handling procedures for the irrigation adaptor and specifically not to overtighten.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.A follow-up report will be submitted should additional information become available.
Event or Problem Description
The user facility reported via medwatch mw5117588 that the irrigation adaptor that connects the irrigation tubing to the endoscopy tower leaks.No report of injury.

• Brand Name: DEFENDO OLYMPUS SINGLE USE VALVE KIT
• Common Device Name: DEFENDO - OLYMPUS VALVE KIT
• 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: 17187920
• Report Number: 1651395-2023-00015
• Device Sequence Number: 14891709
• Product Code: ODC
• UDI-Device Identifier: 00677964092992
• UDI-Public: 00677964092992
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/22/2023

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: 100322
• Device Lot Number: 574186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2023
• 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