MAUDE Adverse Event Report: HITACHI LTD, HEALTHCARE BUSINESS UNIT C41V PROBE; CV41 PROBE

Device Problem Use of Device Problem (1670)

Patient Problems No Code Available (3191); Missing Value Reason (3192)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

Hitachi received a complaint regarding a c41v probe on 6/18/2020.The c41v is a convex array electronic scanning probe.This probe is designed for use as connected with hitachi ultrasound scanner.The noblus us system was used in association with the probe.The site also used a 18g - 20cm needle with a re-usable needle guide to conduct the procedure.The site physician assistant conducted the prostate biopsy procedure and then contacted hitachi to report a failed procedure; no prostate tissue was collected during the procedure.The procedure was conducted on (b)(6) 2020.The patient is doing well.A second biopsy procedure has been scheduled for the patient.Hitachi ultrasound application specialist and service engineer visited the site to conduct thorough evaluations of the noblus us system, c41v probe, needle guide, and 18g - 20cm needle.The needle guide and 18g - 20cm needle are not hitachi's products.The noblus us system and c41v probe passed hitachi's on site qa checks.Ultrasound application specialist tested the usage of the noblus, c41v probe, needle guide, and needle using water and phantom test.All four components passed the water and phantom test.The components operated as intended.Hitachi also asked for biopsy results from previous procedures.The site reported that previous biopsy was successful using these four components.

Event Description

On june 18, 2020 hitachi received report regarding a failed biopsy procedure from a site.The site was using the noblus ultrasound system and c41v probe.

• Brand Name: C41V PROBE
• Type of Device: CV41 PROBE
• Manufacturer (Section D): HITACHI LTD, HEALTHCARE BUSINESS UNIT; 2-1 shintoyofuta; kashiwa-shi, chiba-ken 277-0 704; JA 277-0704
• Manufacturer (Section G): HITACHI LTD., HEALTHCARE BUSINESS UNIT; 2-1 shinotoyofuta; kashiwa-shi, chiba-ken 277-0 804; JA 277-0804
• Manufacturer Contact: jessie san ; 1959 summit commerce park; twinsburg, oh ; 4251313356
• MDR Report Key: 10272114
• MDR Text Key: 201853413
• Report Number: 8030405-2020-00002
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other