FDA Adverse Event Injury Summary report: N

SYMBIA T-SERIES

MDR report key: 3364716 · Received September 20, 2013

Report

Report Number: 1423253-2013-00004
Event Type: Injury
Date Received: September 20, 2013
Date of Event: August 20, 2013
Report Date: August 23, 2013
Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP
Product Code: KPS
PMA / PMN Number: K082506
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL BRAND NAME: E. CAM, SYMBIA E, SYMBIA S. ADDITIONAL DEVICE INFO: AFFECTED MODEL NUMBERS: 04380213, 04380221, 05242826, 05977066, 05977074, 05984005, 05989079, 05989087, 05989095, 05991109, 05991117, 05992099, 07324119, 07324135, 07324143, 07324150, 07760809, 07760932, 07761161, 07823946, 07823953, 07823979, 10151531, 10151532, 10275879, 10413009, 10520745, 10275007, 10275008, 10275009, 10275010. THERE ARE FOUR APPLICABLE 510 (K): E.CAM: K992731. SYMBIA E SINGLE/DUAL: K072567, K082506. SYMBIA S AND T SERIES: K082506.

Description of Event or Problem · 1

A SIEMENS SERVICE ENGINEER (SIEMENS EMPLOYEE) WAS PERFORMING A PREVENTATIVE MAINTENANCE SERVICE ON A CUSTOMER SYSTEM. THE SERVICE ENGINEER HAD OPENED THE LEFT COVER AND WAS INSPECTING FOR ANY MECHANICAL FRICTION OR TENSION OF THE BELT DRIVE. THE SYSTEM REMOTE CONTROL WAS AT HIS HAND AND HE ACCIDENTLY PRESSED THE MOTION BUTTON AND THE DRIVE RESPONDED TO THE MOTION BUTTON ENTRY. HIS RIGHT INDEX FINGER WAS CAUGHT WITHIN THE DRIVE ASSEMBLY. THIS RESULTED IN A SERIOUS INJURY IN WHICH THE TOP PORTION OF HIS RIGHT INDEX FINGER WAS SURGICALLY AMPUTATED. SERVICE MANUALS EXIST WHICH DESCRIBE FULL FUNCTIONALITY OF THE SYSTEMS BEING SERVICED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
476661	SYMBIA T-SERIES	GAMMA CAMERA	KPS	SIEMENS MEDICAL SOLUTIONS USA, INC. MI GROUP	10275007

Patients

Seq	Age	Sex	Outcome	Treatment
1	27 YR		Disability