• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STORZ STORZ UROLOGY CYSTOSCOPE GRASPERS

  • 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
 

STORZ STORZ UROLOGY CYSTOSCOPE GRASPERS Back to Search Results
Lot Number NT 02
Device Problems Break (1069); Product Quality Problem (1506); Device Unsafe to Use in Environment (2918); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Event Description

I am writing to inform you of our now fourth incident of graspers breaking in the last six months. The quality of this instrumentation is unacceptable and places our pts at a major safety risk. In the 8 years i have worked with storz instrumentally i have never seen the prevalence of breakage that we are seeing in these urology graspers. We cannot in good conscious continue to use this product on our pts knowing the ongoing quality issues that have been repeatedly demonstrated with these graspers. There has obviously been a change in the product line for urology. On four separate occasions we have had graspers break while being used on a pt. One incident required a piece to be retrieved from the pt's bladder so as not to be retained. We have now had four graspers break in various procedures, two while in a pt. I have serious concerns from a safety perspective regarding this equipment. Urology cystoscope graspers instrument number (b)(4)-lot number nt 02. Dates of use: 6 months. Diagnosis or reason for use: urological cases.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTORZ UROLOGY CYSTOSCOPE GRASPERS
Type of DeviceSTORZ UROLOGY CYSTOSCOPE GRASPERS
Manufacturer (Section D)
STORZ
MDR Report Key5942466
MDR Text Key54582325
Report NumberMW5064654
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/06/2016
4 DeviceS WERE Involved in the Event: 1   2   3   4  
0 PatientS WERE Involved in the Event:
Date FDA Received09/06/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT NumberNT 02
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-