MAUDE Adverse Event Report: STORZ STORZ UROLOGY CYSTOSCOPE GRASPERS

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.

• Brand Name: STORZ UROLOGY CYSTOSCOPE GRASPERS
• Type of Device: STORZ UROLOGY CYSTOSCOPE GRASPERS
• Manufacturer (Section D): STORZ
• MDR Report Key: 5942466
• MDR Text Key: 54582325
• Report Number: MW5064654
• Device Sequence Number: 1
• Product Code: FAJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/06/2016
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: NT 02
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1