MAUDE Adverse Event Report: HITACHI, LTD. HITACHI; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number C41V

Device Problems Poor Quality Image (1408); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 06/03/2020

Event Type  malfunction  

Event Description

The procedure was a transrectal ultrasound and prostate biopsy performed under monitored anesthesia.During the procedure the ultrasound probe seemed to be giving an adequate image although it was not as clear as it usually is; prostate ultrasound images can be less clear for many reasons including patient anatomy and abnormal prostates so it's not an unusual occurrence.The 12 core biopsy went well with no complications.The pathology report showed that none of the specimens contained prostate tissue.I informed the dr.And 5 days later the ultrasound unit was tested using a phantom prostate and showed the probe to be malfunctioning and not aiming properly.We immediately cancelled the upcoming prostate procedures using this machine.The patient will need to undergo another procedure to obtain the needed biopsy information.

• Brand Name: HITACHI
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): HITACHI, LTD.; 1959 summit commerce park; twinsburg OH 44087
• MDR Report Key: 10407147
• MDR Text Key: 202930976
• Report Number: 10407147
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C41V
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA