MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS ENDO CARRY-ON PROCEDURE KIT; ENDOSCOPIC IRRIGATION/ SUCTION SYSTEM

Lot Number 918726

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 07/19/2018

Event Type  malfunction  

Event Description

Surgical unit was prepping for endo procedure.Endo kit was opened and staff member observed a fly on a 4x4.Medivators inc., ref cpk-107520-0001, lot #918726, exp 03/20/2020.

• Brand Name: MEDIVATORS ENDO CARRY-ON PROCEDURE KIT
• Type of Device: ENDOSCOPIC IRRIGATION/ SUCTION SYSTEM
• Manufacturer (Section D): MEDIVATORS; conroe TX 77303
• MDR Report Key: 7713918
• MDR Text Key: 114972826
• Report Number: MW5078527
• Device Sequence Number: 1
• Product Code: OCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2020
• Device Lot Number: 918726
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1