MAUDE Adverse Event Report: KARL STORZ LITHOTRIPSY-AMERICA INC. STORZ LITHOTRITE STONE CRUSHER

Device Problem Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Date 05/04/2016

Event Type  malfunction  

Event Description

Patient underwent transurethral resection of a large bladder tumor and cystolitholapaxy.During the cystolitholapaxy, the surgeon used the lithotrite stone crusher to crush stone.While bringing the scope back out through the urethra, the stone was upturned and at the tip of the urethra, the stone crusher opened and surgeon was unable to pull the instrument out.The storz rep was contacted for instructions on how to remove the instrument out of the urethra.Eventually the surgeon pushed the stone out of the stone crusher and was able to pull out the stone crusher with some trauma to the tip of the penis.The stone was removed as well.There was a question if there was a metal piece lost from the stone crusher instrument.X-ray was taken after the case and confirmed no retained foreign object.A foley catheter was inserted.The patient will be discharged with the foley catheter, to be left in for a few days, to allow for the urethra to heal.No bleeding at the urethral meatus on post op day 1.

• Brand Name: STORZ LITHOTRITE STONE CRUSHER
• Type of Device: STONE CRUSHER
• Manufacturer (Section D): KARL STORZ LITHOTRIPSY-AMERICA INC.; kennesaw GA
• MDR Report Key: 5641188
• MDR Text Key: 44887513
• Report Number: MW5062152
• Device Sequence Number: 1
• Product Code: FFL
• 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: 05/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• 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
• Patient Age: 83 YR
• Patient Weight: 1