MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA IGS 540; INTERVENTIONAL FLUOROSCOPIC X-RAY

Model Number XCA450

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Congenital Defect/Deformity (1782); Bone Fracture(s) (1870); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)

Event Date 04/27/2017

Event Type  Injury  

Manufacturer Narrative

Ge healthcare¿s investigation is ongoing.A follow up report will be submitted when the investigation is completed.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that during a procedure, while the doctor was moving the table from side to side by holding on the mushroom controller, the smart box fell off of the table and knocked the right foot of the doctor.Despite symptoms of a broken toe (pain, swelling, stiffness, bruising, deformity, and difficultly walking), the doctor completed the procedure.By x-ray, he was diagnosed with 3 fractures on his fifth toe.

Manufacturer Narrative

(b)(6) 2017, date on which this final mdr report has been submitted.First attempt to correct block of the initial report to (b)(6) 2017 was unsuccessful.

Manufacturer Narrative

Date of this report :corrected data to (b)(6) 2017, date on which the initial mdr report has been submitted.Device evaluated by manufacturer: yes.

Manufacturer Narrative

Date of this report: updated to may 15, 2017, date on which the initial report has been submitted.Ge healthcare investigation about this event has been completed.On (b)(4) 2017 it was reported that during a procedure, the smart box fell off of the table, striking the right foot of the doctor.He was diagnosed with 3 fractures on his little toe (fifth digit) which resulted in a serious injury.Ge healthcare field service engineer confirmed that the customer technician did not clamp appropriately this smart box on the table rail and did not check the mechanical lock between the smart box and the table rail.Adequate instructions are provided in operator manual (om) provided with the system for checking the smart box fixation before usage.Neither design, assembly or manufacture defect nor failure or malfunction has been identified on the smart box clamping mechanism.Ge healthcare field service engineer reminded hospital staff about proper clamping of smart box on table rail, and replaced the smart box which presented some damages following the fall.Based on this analysis, no further action is required.

• Brand Name: INNOVA IGS 540
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc ; FR
• Manufacturer Contact: elodie fins ; 283 rue de la miniere; buc ; FR
• MDR Report Key: 6566268
• MDR Text Key: 75102413
• Report Number: 9611343-2017-00007
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122457
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XCA450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention