MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC SIGNA PET/MR; TOMOGRAPHIC IMAGER COMBINING

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 09/03/2021

Event Type  Injury  

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.

Event Description

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.

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.

• Brand Name: SIGNA PET/MR
• Type of Device: TOMOGRAPHIC IMAGER COMBINING
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• Manufacturer (Section G): GE MEDICAL SYSTEMS, LLC; 3200 n grandview blvd.; waukesha, WI 53188
• Manufacturer Contact: andy koch ; 3200 n. grandview blvd.; waukesha, WI 53188
• MDR Report Key: 12563091
• MDR Text Key: 274356885
• Report Number: 2183553-2021-00010
• Device Sequence Number: 1
• Product Code: OUO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 100 KG