MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC TRICEP THREE PRONG GRASPER; UROLOGIC DEVICE FOR STONE REMOVAL

Model Number M0063701190

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/15/2014

Event Type  malfunction  

Event Description

Boston scientific three prong grasper tricep used to retrieve ureteral stone fragment from left ureter.The three prongs detached from the catheter during the procedure.

• Brand Name: BOSTON SCIENTIFIC TRICEP THREE PRONG GRASPER
• Type of Device: UROLOGIC DEVICE FOR STONE REMOVAL
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 4377634
• MDR Text Key: 19765842
• Report Number: MW5039850
• 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: 12/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2014
• Device Model Number: M0063701190
• Device Lot Number: 17280866
• Other Device ID Number: 3434657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2014
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 113