MAUDE Adverse Event Report: MEDIVATORS DISPOSABLE DEFENDO SUCTION VALVE; DISPOSABLE SUCTION VALVE FOR GI ENDOSCOPES

Lot Number	415963
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by the facility that during an upper gi endoscopy procedure a defendo single use suction valve was reported to be stuck in the endoscope.Due to the length of the procedure, the patient was taken to the medical intensive care unit.Medivators was notified through a medwatch report mw5088292 that the facility reported a patient had a procedure for esophageal stent repositioning.It was reported that during the procedure the defendo single use suction valve became stuck and then broke inside the endoscope when the physician attempted to remove it.The physician then was provided a new endoscope to finish the procedure.It was reported the procedure took longer than expected due to reported malfunctions in two separate devices.The second reported device is not a medivators product.Due to the length of the procedure there was reported concern for airway edema.The patient was transferred to the medical intensive care unit where the patient was extubated with no complications.There was no device returned to medivators for investigation.Medivators followed up with the facility but limited additional information was provided related to this event.Medivators remains in close contact with the facility.This complaint will continue to be monitored in the medivators complaint handling system.
Event or Problem Description
It was reported by the facility that during an upper gi endoscopy procedure a defendo single use suction valve was reported to be stuck in the endoscope.Due to the length of the procedure, the patient was taken to the medical intensive care unit.

• Brand Name: DISPOSABLE DEFENDO SUCTION VALVE
• Common Device Name: DISPOSABLE SUCTION VALVE FOR GI ENDOSCOPES
• Manufacturer (Section D): MEDIVATORS; 3150 pollok drive; conroe TX 77303
• MDR Report Key: 8971027
• Report Number: 1651395-2019-00003
• Device Sequence Number: 14064632
• Product Code: ODC
• UDI-Device Identifier: 00677964060250
• UDI-Public: 00677964060250
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 09/06/2019

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: No Information
• Device Lot Number: 415963
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LOOP CUTTER
• Outcome Attributed to Adverse Event: Other