MAUDE Adverse Event Report: TURBETT SURGICAL, INC. TURBETT POD; WRAP, STERILIZATION

Model Number TS1500

Device Problems Material Separation (1562); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

Event Type  malfunction  

Event Description

Breach at the seam of the turbett pod (instrument containment system) which renderers the instruments contaminated.Fda safety report id# (b)(4).

• Brand Name: TURBETT POD
• Type of Device: WRAP, STERILIZATION
• Manufacturer (Section D): TURBETT SURGICAL, INC.
• MDR Report Key: 11938387
• MDR Text Key: 254591119
• Report Number: MW5101702
• Device Sequence Number: 1
• Product Code: FRG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TS1500
• Device Lot Number: 100036
• Was Device Available for Evaluation?: No
• 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