MAUDE Adverse Event Report:; PRESURGCIAL SCOPE WARMER

Catalog Number PS-500

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 09/12/2018

Event Type  malfunction  

Event Description

The metal tab in the scope warmer broke in half and the contents of the warmer leaked out.We removed all of items that the warmer touched and got new ones.

• Type of Device: PRESURGCIAL SCOPE WARMER
• MDR Report Key: 7951738
• MDR Text Key: 123350045
• Report Number: 7951738
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: PS-500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2018
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Age: 17520 DA