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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT SYSTEM
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NEOTRACT, INC. NEOTRACT UROLIFT SYSTEM Back to Search Results
Model Number UROLIFT SYSTEM
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/27/2020
Type of Reportable Event Malfunction
Event or Problem Description
On 27 october 2020, neotract was made aware of a physician that experienced multiple delivery devices that did not properly deploy during the prostatic urethral lift (pul) procedure.The procedure was successfully completed using additional devices.On (b)(6) 2020, neotract's device analysis indicated that one of the returned devices was missing approximately 2mm of the needle tip.Neotract notified the physician of the investigation results.No additional information is available at this time.
 
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Brand Name
NEOTRACT UROLIFT SYSTEM
Common Device Name
UROLIFT SYSTEM
Manufacturer (Section D)
NEOTRACT, INC.
4155 hopyard road
pleasanton CA 94588
MDR Report Key11029381
Report Number3005791775-2020-00054
Device Sequence Number16310498
Product Code PEW
UDI-Device Identifier10814932020152
UDI-Public10814932020152
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K193269
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/17/2020
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
Operator of Device Health Professional
Device Model NumberUROLIFT SYSTEM
Device Catalogue NumberIPN056625
Device Lot NumberP45437
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/02/2020
Initial Report FDA Received Date12/17/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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