FDA Adverse Event Injury Summary report: N

TOSHIBA

MDR report key: 2551611 · Received April 27, 2012

Report

Report Number: 2020563-2012-00006
Event Type: Injury
Date Received: April 27, 2012
Date of Event: March 29, 2012
Report Date: March 30, 2012
Manufacturer: TOSHIBA MEDICAL SYSTEMS CORPORATION
Product Code: JAK
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ON (B)(6) 2012, A SERVICE CALL WAS PLACED STATING THAT THE ALIGNMENT LASERS WERE OUT OF ADJUSTMENT BY 16 MM COMPARED TO THE TABLE POSITION. UPON INVESTIGATION, IT WAS DISCOVERED THAT THE LASERS WERE PROPERLY ADJUSTED, HOWEVER, A BIOPSY WAS CONDUCTED THAT RESULTED IN A TABLE LOCATION THAT WAS APPROXIMATELY 16MM OFF TARGET. UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT A USER ORIGINATED PROTOCOL RESULTED IN THE UNEXPECTED TABLE POSITION. TOSHIBA EMPLOYEE ASSISTED IN THE CORRECTION OF THE PROTOCOL AND TABLE POSITION IS NOW AS EXPECTED. RESULTS: THE INVESTIGATION INTO THIS ISSUE HAS NOT BEEN COMPLETED. NO RESULTS AS YET. CONCLUSIONS: THE INVESTIGATION INTO THIS ISSUE HAS NOT BEEN COMPLETED. NO CONCLUSIONS AS YET.

Additional Manufacturer Narrative · 1

THE MANUFACTURER CONDUCTED AN INVESTIGATION INTO THIS ISSUE AND CONCLUDED THAT THE CAUSE OF THE PROBLEM WAS INADEQUATE NEEDLE POSITIONING (THE USER DID NOT CONFIRM REGION OF INTEREST AND TABLE LOCATION). THEREFORE CAUSING THE BIOPSY NEEDLE TO BE INSERTED IN THE WRONG POSITION IN THE PATIENT. THERE WAS NO DEFECT FOUND IN THE CT SYSTEM. THE INVESTIGATION IS CONSIDERED CLOSED.

Description of Event or Problem · 1

DURING A CT PROCEDURE, THE BIOPSY SITE WAS MISSED BY 16MM CAUSING THE PATIENT TO SUFFER A COLLAPSED LUNG.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TOSHIBA	COMPUTED TOMOGRAPHY SYSTEM	JAK	TOSHIBA MEDICAL SYSTEMS CORPORATION	TSX-101A/FD

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other