MAUDE Adverse Event Report: BOSTON SCIENTIFIC ULTRASOUND PROBE; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number M0068407170

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Material Twisted/Bent (2981)

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

Event Date 01/10/2019

Event Type  malfunction  

Event Description

Upon opening from original mfr packaging, the boston scientific, 3.8 mm x 403 mm ultrasound probe was noted to be bent.

• Brand Name: ULTRASOUND PROBE
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 8253647
• MDR Text Key: 133712061
• Report Number: MW5083160
• Device Sequence Number: 1
• Product Code: ITX
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2021
• Device Model Number: M0068407170
• Device Catalogue Number: M0068407170
• Device Lot Number: 22696614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2019
• 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