MAUDE Adverse Event Report: TELEFLEX MEDICAL SURGICAL UNKNOWN

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.

• Brand Name: SURGICAL UNKNOWN
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate NC 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 9083530
• MDR Text Key: 162783291
• Report Number: 3011137372-2019-00304
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 544240
• 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 Received: 04/29/2020
• 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