MAUDE Adverse Event Report: MEDIVATORS INC. ENDOGATOR; ENDOSCOPIC IRRIGATION/SUCTION SYSTEM

Catalog Number 100601

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 06/27/2017

Event Type  malfunction  

Event Description

While setting up equipment for colonoscopy, the rn noted the 6 inch rubbery part of the irrigation tubing would not connect to the water port.Another irrigation tubing kit was obtained and utilized without difficulty.Malfunctioning equipment was saved.

• Brand Name: ENDOGATOR
• Type of Device: ENDOSCOPIC IRRIGATION/SUCTION SYSTEM
• Manufacturer (Section D): MEDIVATORS INC.; 3150 pollok drive; conroe TX 77303
• MDR Report Key: 6806769
• MDR Text Key: 83120654
• Report Number: 6806769
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: 100601
• Device Lot Number: 842953
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; OLYMPUS COLONSCOPE
• Patient Age: 67 YR
• Patient Weight: 90