MAUDE Adverse Event Report: SOMATOM SCOPE POWER (DE); SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	10046799
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporting facility phone number and contact name were not provided to siemens.The event was reported by a siemens employee.Siemens performed technical evaluation of the reported event and system.The plexi-ring had aged and had become brittle, requiring a replacement which was performed.The system user manual cautions against performing maintenance and other tasks while the gantry is in motion.The root cause is use error.No device malfunction or general design were identified.
Event or Problem Description
It was reported to siemens that the plexi-ring of the ct gantry cover has jumped out of its track due to a missing/broken plastic lock.The facility technician attempted to push the plexi-ring back into its original position but did not wait until the gantry stopped rotating.The technician's finger got caught in the rotating parts and a moderate injury to the digit was sustained.It was reported that both the skin and muscle of the digit were injured.The injury was treated by suturing the laceration.There was no permanent damage to the technician's finger.This incident is considered a work accident and no malfunction or general design issue were reported.The reported event occurred in (b)(6).

• Brand Name: SOMATOM SCOPE POWER (DE)
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 11715155
• Report Number: 3004977335-2021-74648
• Device Sequence Number: 4427545
• Product Code: JAK
• UDI-Device Identifier: 04056869013053
• UDI-Public: 04056869013053
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K183548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10046799
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention