MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS JETPREP; ENDOSCOPIC FLUSHING DEVICE

Model Number JP30022

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fever (1858); Chills (2191); Bowel Perforation (2668); No Code Available (3191)

Event Date 02/05/2015

Event Type  No Answer Provided  

Event Description

Physician noted markings and discoloration on the colon lining during the procedure with a medivators jetprep endoscopic flushing device.Patient experienced micro perforation, fever, and chills later the same day and went to the er.It has not been confirmed that use of the product is directly related to this.

Manufacturer Narrative

The case states that the physician noted markings and discoloration on the colon lining during a procedure with the medivators jetprep endoscopic flushing device on an elderly female patient.Patient experienced micro perforation, fever, and chills later the same day and went to the er.It has not been confirmed that use of the product is directly related to this.There is no information regarding the patient condition or symptoms prior to the procedure and there is limited information regarding the current patient status.Physician disposed product.

• Brand Name: MEDIVATORS JETPREP
• Type of Device: ENDOSCOPIC FLUSHING DEVICE
• Manufacturer (Section D): MEDIVATORS; 3150 pollok dr.; conroe TX 77303
• Manufacturer (Section G): MEDIVATORS; 3150 pollok dr.; conroe TX 77303
• Manufacturer Contact: kristin bergeson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533300
• MDR Report Key: 4542241
• MDR Text Key: 16304348
• Report Number: 1651395-2015-00002
• Device Sequence Number: 1
• Product Code: OCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K1122740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: JP30022
• Device Lot Number: 22019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization