MAUDE Adverse Event Report: TOSHIBA AMERICA MEDICAL SYSTEMS, INC. TOSHIBA ARTIDA PET-512 MC TRANSDUCER/ PROBE; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Catalog Number PET-512MC

Device Problem Material Puncture/Hole (1504)

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

Event Date 06/22/2015

Event Type  malfunction  

Event Description

After performing a transesophageal echocardiogram (tee) during open heart surgery, the tee probe was pulled and cleaned in cidex opa.The probe was in a civo transducer cover during the entire procedure and the probe itself did not touch the patient's mucous membranes.After the cleaning process a small puncture with clear liquid draining out of it was observed.

• Brand Name: TOSHIBA ARTIDA PET-512 MC TRANSDUCER/ PROBE
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): TOSHIBA AMERICA MEDICAL SYSTEMS, INC.; 2441 michelle drive; tustin CA 92780
• MDR Report Key: 4951959
• MDR Text Key: 18720538
• Report Number: 4951959
• Device Sequence Number: 1
• Product Code: ITX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/23/2015

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: Physician
• Device Catalogue Number: PET-512MC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2015
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2015
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 112