Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK XL CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TELEFLEX MEDICAL HEMOLOK XL CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE Back to Search Results
Catalog Number 544250
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/09/2014
Event Type  Injury  
Event Description
Reported in a medical journal, the report states, "a 54-year-old man underwent a robot-assisted radical prostatectomy for prostate cancer on june 2014.He had been fine after the operation, but urinary frequency and hematuria occurred after 3 months.A 7 mm stone shadow was found in the bladder by ultrasound and ct scan, and a non-mobile stone was found at the 9 o'clock position at the vesicourethral anastomosis by cystoscopy.The patient was diagnosed as a bladder stone and transurethral bladder lithotripsy was performed.When the surface of the stone was crushed, the clip that had been used during the radical prostatectomy appeared from inside.The clip was removed with forceps, all stones were crushed and removed, and the surgery was completed.The patient has been fine after the surgery and no migration of the clip has been observed after that".No patient harm or injury.The patient status is reported as "fine".
 
Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
 
Event Description
Reported in a medical journal, the report states, "a 54-year-old man underwent a robot-assisted radical prostatectomy for prostate cancer on june 2014.He had been fine after the operation, but urinary frequency and hematuria occurred after 3 months.A 7 mm stone shadow was found in the bladder by ultrasound and ct scan, and a non-mobile stone was found at the 9 o'clock position at the vesicourethral anastomosis by cystoscopy.The patient was diagnosed as a bladder stone and transurethral bladder lithotripsy was performed.When the surface of the stone was crushed, the clip that had been used during the radical prostatectomy appeared from inside.The clip was removed with forceps, all stones were crushed and removed, and the surgery was completed.The patient has been fine after the surgery and no migration of the clip has been observed after that".No patient harm or injury.The patient status is reported as "fine".
 
Manufacturer Narrative
(b)(4).Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.Dhr review could not be conducted since the lot number was not provided.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Other remarks: n/a.Corrected data: n/a.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEMOLOK XL CLIPS 6/CART 84/BOX
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate 21478
MX   21478
Manufacturer Contact
mariah mackinnon
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key17998020
MDR Text Key326420276
Report Number3003898360-2023-01434
Device Sequence Number1
Product Code FZP
UDI-Device Identifier34026704625216
UDI-Public34026704625216
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K133202
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number544250
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/07/2023
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 Initial
Patient Sequence Number1
Patient Age54 YR
Patient SexMale
-
-