MAUDE Adverse Event Report: KARL STORXZ SE & KG ULTRASONIC LITHOTRIPSY PROBE WITH OSCILLATING BURR TIP

Model Number 27093LK

Device Problems Break (1069); Suction Failure (4039)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2019

Event Type  Injury  

Event Description

The tip broke approximately 2" from where the tip is threaded into the hand held motor portion.User noticed loss of suction while in use, pulling the motor from the sheath user noticed there was only a portion of the burr still attached to the motor.The rest of the burr was still in the sheath and we were able to retrieve it because a portion was sticking ou the sheath.

• Brand Name: ULTRASONIC LITHOTRIPSY PROBE WITH OSCILLATING BURR TIP
• Type of Device: ULTRASONIC LITHOTRIPSY PROBE
• Manufacturer (Section D): KARL STORXZ SE & KG; el segundo CA
• MDR Report Key: 8465428
• MDR Text Key: 140431935
• Report Number: MW5085354
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27093LK
• Device Lot Number: 51791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 71