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Catalog Number 544240
Device Problems Entrapment of Device (1212); Migration (4003)
Patient Problems Pain (1994); Hematuria (2558); Dysuria (2684)
Event Date 10/15/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Event Description
The complaint states: in (b)(6) 2015, the patient underwent robotic radical prostatectomy whereby holc were placed outside of his bladder as part of the ligation process. Nearly two years after his prostatectomy, in (b)(6) 2017, he presented with severe pelvic/perineal pain, painful urination, blood in urine, erectile dysfunction and overall discomfort. Upon examination, physicians found that the holc had perforated and entered his bladder. They found two stones inside his bladder, growing on two separate weck holc. A large one-centimeter stone was found at the base of the bladder neck. The bladder neck is a group of muscles that connect the urethra to the bladder. Bladder neck contracture and the formation of bladder stones is known complication of radical prostatectomies and can lead to permanent injury. According to the patient's medical records, the stone is likely associated with the holc. The smaller stone, emanating from the left ureteral orifice was also growing on an holc inside of his bladder. In (b)(6) 2019, two years after the first removal procedure, he once again presented with discomfort during urination, blood in urine, and pelvic/perineal pain. A single holc was identified at the base of the stone but did not perforate the bladder as before.
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Manufacturer (Section D)
morrisville NC
Manufacturer (Section G)
rancho el descanso
tecate NC 21478
MX 21478
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key9083530
MDR Text Key162783291
Report Number3011137372-2019-00304
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number544240
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/18/2019 Patient Sequence Number: 1