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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT ADVANCED TISSUE CONTROL SYSTEM; UROLIFT ATC SYSTEM
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NEOTRACT, INC. NEOTRACT UROLIFT ADVANCED TISSUE CONTROL SYSTEM; UROLIFT ATC SYSTEM Back to Search Results
Model Number UROLIFT ATC SYSTEM
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/17/2020
Type of Reportable Event Malfunction
Event or Problem Description
On 17 august 2020, neotract was informed of a prostatic urethral lift (pul) procedure during which the physician noted that a device appeared to not deploy properly.The procedure was completed successfully and no patient harm or injury was reported.On 2 september 2020, neotract's investigation of the returned device indicated that it was missing 1-2mm of the needle tip.Neotract notified the physician of the investigation results who, on (b)(6) 2020, acknowledged the missing needle piece and stated that he did not feel further evaluation was warranted.
 
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Brand Name
NEOTRACT UROLIFT ADVANCED TISSUE CONTROL SYSTEM
Common Device Name
UROLIFT ATC SYSTEM
Manufacturer (Section D)
NEOTRACT, INC.
4155 hopyard road
pleasanton CA 94588
MDR Report Key10621527
Report Number3005791775-2020-00046
Device Sequence Number3885428
Product Code PEW
UDI-Device Identifier10814932020145
UDI-Public10814932020145
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K200441
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/02/2020
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 ATC SYSTEM
Device Catalogue NumberUL400-ATC
Device Lot NumberP44288
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/17/2020
Initial Report FDA Received Date10/02/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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