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U.S. Department of Health and Human Services

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

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TURBETT SURGICAL, INC. TURBETT POD WRAP, STERILIZATION Back to Search Results
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 (surgical instrument containment system) which renders instruments contaminated. Fda safety report id # (b)(4).
 
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Brand NameTURBETT POD
Type of DeviceWRAP, STERILIZATION
Manufacturer (Section D)
TURBETT SURGICAL, INC.
MDR Report Key11938374
MDR Text Key254587647
Report NumberMW5101701
Device Sequence Number1
Product Code FRG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTS1500
Device Lot Number100036
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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