FDA Adverse Event Injury Summary report: N

TOSHIBA

MDR report key: 1368185 · Received April 15, 2009

Report

Report Number: 2020563-2008-00006
Event Type: Injury
Date Received: April 15, 2009
Date of Event: March 12, 2009
Report Date: March 17, 2009
Manufacturer: TOSHIBA MEDICAL SYSTEM CORP
Product Code: ITX
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

METHOD: DEVICE NOT RETURNED; EVALUATION CANNOT BE CONDUCTED. PER DR. WULRICH IT TOOK THREE TRIES TO INSERT THE TRANSDUCER. AFTER A SUCCESSFUL INSERTION ON THE THIRD ATTEMPT, THERE WAS NO NOTED RESISTANCE OR DIFFICULTY IN THE INSERTION PROCESS. THE ACTUAL PROCEDURE TOOK PLACE IN 2009, AND THE PATIENT AT THE END OF THE PROCEDURE COMPLAINED OF A SORE THROAT. THE PHYSICIAN HAD THE ENT DEPARTMENT EVALUATE THE PATIENT, AND NO PROBLEMS WERE FOUND. THE ENT EVALUATION WAS CONDUCTED ON THE UPPER LARYNX AND DID NOT INVOLVE THE ESOPHAGUS. THE PHYSICIAN STATED THAT HE WAS INFORMED THAT THE INJURY WAS A RUPTURED ESOPHAGUS AND A FOLLOW-UP WAS CONDUCTED BY THE PATIENT'S REFERRING PHYSICIAN, CARDIOTHORACIC SURGEON. TOSHIBA AMERICA MEDICAL SYSTEMS HAS BEEN UNABLE TO MAKE CONTACT WITH DR. TO DATE. TOSHIBA AMERICA MEDICAL SYSTEMS PROVIDED AN ADVISORY NOTICE FOR THE SAFE USE OF THE TRANSDUCER TO THE MEDICAL CENTER ON OR ABOUT DECEMBER 2, 2008. THE TRANSDUCER IS NOT BEING RETURNED BY THE CUSTOMER. CUSTOMER IS CONTINUING TO USE THE TRANSDUCER.

Description of Event or Problem · 1

COMPLICATION FOLLOWING A TEE PROCEDURE. THE PATIENT WAS SENT FOR A CT SCAN AFTER COMPLAINING ABOUT A SORE THROAT. THE CT SCAN INDICATED A TORN ESOPHAGUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TOSHIBA	TRANSDUCER, DIAGNOSTIC ULTRASOUND	ITX	TOSHIBA MEDICAL SYSTEM CORP	PET-511BTM

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other