inforMED
InjuryOUO

SIGNA PET/MR

Received Oct 1, 2021 · Event occurred Sep 3, 2021

Report 2183553-2021-00010 · MDR key 12563091

Device

Generic name

Tomographic Imager Combining

Product problems

  • Use of Device Problem
  • Use of Device Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

52 YR · Male

  • Laceration(s)
  • Laceration(s)

Narrative

Additional Manufacturer Narrative

H3: THE INVESTIGATION BY GE HEALTHCARE (GEHC) HAS BEEN COMPLETED. BASED ON THE INFORMATION PROVIDED, THE INCIDENT OCCURRED DUE TO A FAILURE TO FOLLOW SERVICE PROCEDURES BY THE GE FIELD ENGINEER (FE). THE FE DID NOT FOLLOW THE PROPER STET TOOL PROCEDURE WHICH SPECIFICALLY INSTRUCTS THE USER THAT THE TOOL IS INTENDED FOR SINGLE PERSON OPERATION ONLY. THE FE HAS BEEN REINSTRUCTED ON THE PROPER OPERATION OF THE STET TOOL.

Additional Manufacturer Narrative

COMMON DEVICE NAME: TOMOGRAPHIC IMAGER COMBINING EMISSION COMPUTED TOMOGRAPHY WITH NUCLEAR MAGNETIC RESONANCE UNIQUE IDENTIFIER: (B)(4). THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

Description of Event or Problem

IT WAS REPORTED THAT DURING INSTALLATION OF A PET/MR SYSTEM, TWO FIELD ENGINEERS (FE) WERE PLACING SHIM TRAYS INTO THE MR SYSTEM. WHILE THEY WERE IN THE PROCESS OF PUSHING A SHIM TRAY INWARD USING A SPECIALIZED GE HEALTHCARE SERVICE TOOL, ONE OF THE FE'S GLOVES HAD BECOME CAUGHT AND HIS FINGER PINCHED. THE PINCH RESULTED IN A LACERATION OF HIS LEFT INDEX FINGER WHICH REQUIRED SEVEN SUTURES.