MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC PRECISION 500D R&F X-RAY SYSTEM; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I

Model Number 2290800

Device Problems Defective Component (2292); Adverse Event Without Identified Device or Use Problem (2993); Sharp Edges (4013)

Patient Problems Abrasion (1689); Laceration(s) (1946); Suture Abrasion (2497)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

Ge healthcare has initiated a root cause investigation which is ongoing.A follow-up report will be submitted when the investigation has completed.Patient identifier: patient identifier was not provided.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2019, the radiology manager at baptist north medical campus in the usa reported to ge healthcare that on (b)(6) , as the radiographic technologist was in the process of lifting the detector into the wall stand bucky tray of their precision 500d system, their left hand impacted the bottom corner edge of the bucky tray and resulted in a posterior left-hand laceration between the first and second digits.This laceration required hands-on treatment and three sutures were applied to prevent infection and to minimize potential scarring.

Manufacturer Narrative

Ge healthcareâs investigation has been completed and the root cause of the event was identified as a supplier manufacturing error.The ge field engineer arrived at the site to investigate this issue and identified the detector tray contained sharp edges/burrs on the trayâs base plate.To correct this issue, the fe replaced the detector tray and then returned the faulty tray for engineering analysis.Visual and physical analysis by engineering confirmed the sharp edges and burrs.An additional inspection was then completed on twenty-two of the same model detector trays that were available as stock at the ge parts warehouse and none of the twenty-two parts showed evidence of burrs or sharp edges.In addition, a historical complaint evaluation was completed and there were no similar events identified.The supplier manufacturing procedure for the detector tray includes a requirement to deburr all edges.The supplier of the detector tray participated in this investigation and is in agreement with the root cause.In conclusion, since there is no evidence of a systemic manufacturing error, this is considered a single manufacturing error and no further actions are needed.

• Brand Name: PRECISION 500D R&F X-RAY SYSTEM
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 9331436
• MDR Text Key: 167338954
• Report Number: 2126677-2019-00016
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: K081091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

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
• Device Model Number: 2290800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 70