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

Model Number EGP-100

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2019

Event Type  malfunction  

Event Description

The gator stopped midway through procedure and caused a delay.

• Brand Name: ENDOGATOR
• Type of Device: ENDOSCOPIC IRRIGATION
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 8925188
• MDR Text Key: 155340137
• Report Number: 8925188
• Device Sequence Number: 1
• Product Code: OCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EGP-100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1