MAUDE Adverse Event Report: BOSTON SCIENTIFIC RIGID PNEUMATIC PROBE; LITHOTRIPTOR ELECTRO - HYDRAULIC

Model Number M0068407330

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/05/2018

Event Type  malfunction  

Event Description

Boston scientific 1.0mm x 570mm rigid pneumatic probe opened for case.While plastic roller adjuster could not be moved.

• Brand Name: RIGID PNEUMATIC PROBE
• Type of Device: LITHOTRIPTOR ELECTRO - HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 7471920
• MDR Text Key: 106967945
• Report Number: MW5076828
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• 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: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2021
• Device Model Number: M0068407330
• Device Catalogue Number: M0068407330
• Device Lot Number: 21773500
• Was Device Available for Evaluation?: Yes
• 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 Age: 90 YR