MAUDE Adverse Event Report: MICROTEK MEDICAL INC. TOP DRAPE WARMER DRAPE

Catalog Number ORS-100

Device Problems Contamination (1120); Device Operates Differently Than Expected (2913)

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

Event Date 05/24/2017

Event Type  malfunction  

Event Description

Irrigation warmer drape had a hold that allowed the irrigation to come in contact with unsterile surface.This was brought to surgeon's attention during a chiari decompression surgery.

• Brand Name: TOP DRAPE WARMER DRAPE
• Type of Device: TOP DRAPE WARMER DRAPE
• Manufacturer (Section D): MICROTEK MEDICAL INC.; columbus MS 39702
• MDR Report Key: 7128152
• MDR Text Key: 95237954
• Report Number: MW5074093
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/15/2017

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 Expiration Date: 02/01/2022
• Device Catalogue Number: ORS-100
• Device Lot Number: D170511
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 113