MEDIVATOR ENDOGATER 10241

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-26 for MEDIVATOR ENDOGATER 10241 manufactured by Medivators Inc..

MAUDE Entry Details

• Report Number: MW5089357
• MDR Report Key: 8936162
• Date Received: 2019-08-26
• Date of Report: 2019-08-22
• Date of Event: 2019-08-16
• Date Added to Maude: 2019-08-27
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: MEDIVATOR ENDOGATER
• Generic Name: ENDOSCOPIC IRRIGATION / SUCTION SYSTEM
• Product Code: OCX
• Date Received: 2019-08-26
• Model Number: 10241
• Lot Number: 419075
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDIVATORS INC.

Device Sequence Number: 2

• Brand Name: MEDIVATOR ENDOGATER
• Generic Name: ENDOSCOPIC IRRIGATION / SUCTION SYSTEM
• Product Code: OCX
• Date Received: 2019-08-26
• Model Number: 10241
• Lot Number: 419076
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MEDIVATORS INC.

Device Sequence Number: 3

• Brand Name: MEDIVATOR ENDOGATER
• Generic Name: ENDOSCOPIC IRRIGATION / SUCTION SYSTEM
• Product Code: OCX
• Date Received: 2019-08-26
• Model Number: 10241
• Lot Number: 419084
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: MEDIVATORS INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-08-26