MAUDE Adverse Event Report: TURBETT SURGICAL TURBETT SURGICAL POD; SURGICAL CONTAINER

Device Problem Hole In Material (1293)

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

Event Date 02/07/2018

Event Type  malfunction  

Event Description

Pt for right tka, filter on turbett surgical pod noted to have hole, instrument container returned to central processing for resterilization.Director of surgical services and operations manager of central processing aware and contacted turbett surgical.Operations manager, turbett surgical revietabs were added to help support the screen from distorting.All units within the hospital were updated.Wed the 3 units that produced holes in the filters.Two more.

• Brand Name: TURBETT SURGICAL POD
• Type of Device: SURGICAL CONTAINER
• Manufacturer (Section D): TURBETT SURGICAL
• MDR Report Key: 7292616
• MDR Text Key: 100953834
• Report Number: MW5075465
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2018
• Is the Reporter a Health Professional?: Yes
• 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: 62 YR
• Patient Weight: 113