MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS PRISTINA+ST+CESM+3D; FULL FIELD DIGITAL MAMMOGRAPHIC XRAY

Device Problems Unintended System Motion (1430); Device Slipped (1584); Device Contaminated During Manufacture or Shipping (2969)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Patient age/dob, weight and initials were not provided.No injury occurred, nevertheless, this complaint is conservatively reported to competent authority as a potential risk of a serious injury was considered.Ge healthcare's investigation and medical review discussion are 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 to ge healthcare field service engineer that when a patient was undergoing a stereotaxy procedure with the gantry at - 90 degrees, a gantry rotation brake failure occurred (hole system with stereotaxy moved) with the patient compressed at around 6-7 dan and with the biopsy device connected.No patient injury was reported.

Manufacturer Narrative

Block d5: health professional block h6: on (b)(6), 2019 during a biopsy procedure with the gantry at -90 degrees, an unexpected slippage of the biopsy breast support occurred with the patient compressed at around 6-7 dan.There was no needle inserted at the time of the issue.No patient injury has been reported, other than a bit pain during the rotation.Ge healthcare engineering investigation of this event was performed.Using information provided by ge healthcare field service engineer and from testing the suspected device and devices from the same lot.It has been found that the rotational movement was impacted due to an inadequate tooling and inappropriate part handling in manufacturing environment and also due to inadequate engineering test specifications.This system has been fixed on (b)(6) 2019 by ge healthcare field engineer by replacing the rotation brake and checking brake torque a left right look has been performed, and it was found that all the pristina, serena mammo systems are impacted by this issue.As an immediate correction, a product hold shipment has been initiated on (b)(6)-2019 for biopsy, on (b)(6)-2019 for pristina systems and on 2-may-2019 for angulation and rotation brake fru.As corrective action, fmi 12283 is deployed to fix the issue on installed base and a stop shipment was performed on serena, pristina and brake fru.Design changed has been performed in forward production.Correction action and preventive action is in progress to follow all corrective and preventive actions of the fmi 12283.

Manufacturer Narrative

Corrected data following investigation and root cause update: ge healthcare engineering investigation of this event has been updated.It has been found that the root causes of this issue are: - detector shaft, keys and brake disc dimensions were out of specifications.- design of detector shaft and/or keys, and brake disc were not optimized for manufacturability.- incomplete mitigations with regards to brake management (cmt, design fmea, system fmea, manufacturing pfmeas).Field action 12283 (corresponding to z-2131-2019 and z-2132-2019) is being deployed to fix the issue on installed base.Design change has been performed in forward production.All corrective and preventive actions related to this issue has been provided as part of the capa summary for field action 12283.

• Brand Name: PRISTINA+ST+CESM+3D
• Type of Device: FULL FIELD DIGITAL MAMMOGRAPHIC XRAY
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• MDR Report Key: 8469026
• MDR Text Key: 140613126
• Report Number: 9611343-2019-00002
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• PMA/PMN Number: P130020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 03/04/2019; 03/04/2019
• Supplement Dates FDA Received: 06/18/2019; 09/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other