MAUDE Adverse Event Report: TOSHIBA MEDICAL SYSTEMS CORPORATION TOSHIBA; ULTRASONIC DIAGNOSTIC TRANSDUCER

Model Number PET-512MC

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Device Handling Problem (3265)

Patient Problems No Patient Involvement (2645); Missing Value Reason (3192)

Event Date 06/22/2015

Event Type  malfunction  

Manufacturer Narrative

This medwatch report is being submitted in response to the medwatch report submitted by the customer ((b)(4)).This report was received on august 3, 2015 from fda.It has been determined that a small slit or tear was caused by continued handling and use of the probe.When the probe is cleaned it is soaked in a disinfectant bath.The leaking fluid is the disinfectant solution that permeated into the probe through the tear and depending on how it is hung to dry or held the solution will leak out through the tear.The possibility of this type of failure is a known risk and user information includes instructions for visual inspection before and after use.

Event Description

Following use, a toshiba pet-512mc tee probe was cleaned in cidex opa.According to the medwatch report submitted by the customer, after the cleaning process a small puncture with clear liquid draining out of it was observed.

Manufacturer Narrative

The results of the investigation conducted by the manufacturer shows that the cross section of the slit found near the transducer head is smooth and therefore most probably made by a sharp object when handling the transducer.The possibility of this type of failure is a known risk and user information in the operation manual includes instructions for inspection (visually and electrically) before and after use.The manufacturer believes that the customer did not use the transducer in accordance with the operation manual.

Manufacturer Narrative

The manufacturer will investigate this failed transducer.

• Brand Name: TOSHIBA
• Type of Device: ULTRASONIC DIAGNOSTIC TRANSDUCER
• Manufacturer (Section D): TOSHIBA MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer (Section G): TOSHIBA MEDICAL SYSTEMS CORPORATION; 1385 shimoishigami; otawara-shi, tochigi 324-8 550; JA 324-8550
• Manufacturer Contact: paul biggins ; 2441 michelle drive; tustin, CA 92780 ; 7147305000
• MDR Report Key: 5082697
• MDR Text Key: 26256260
• Report Number: 2020563-2015-00003
• 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: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Risk Manager
• Type of Report: Followup
• Report Date: 08/03/2015

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 Model Number: PET-512MC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1