SHINYOUNG FOR M CO., LTD.
Report
- Report Number
- 0001418964-2025-00001
- Event Type
- Malfunction
- Date Received
- November 25, 2025
- Date of Event
- November 11, 2025
- Report Date
- November 25, 2025
- Manufacturer
- SHINYOUNG FOR M CO., LTD.
- Product Code
- ITZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
ON JANUARY 2, 2026, DEL MEDICAL RECEIVED A NOTIFICATION OF REPORT (B)(4), WHICH WAS SUBMITTED THROUGH FDA'S MEDSUN PROGRAM. THE REPORT INCORRECTLY IDENTIFIES DEL MEDICAL AS THE MANUFACTURER OF THE DEVICE INVOLVED IN THE CASE. THE SAME EVENT WAS ALREADY REPORTED TO THE FDA BY DEL MEDICAL ON NOV 25, 2025 IN REPORT 0001418964-2025-00001. IN THE EVENT DESCRIBED BY BOTH REPORTS, DEL MEDICAL WAS THE DISTRIBUTOR OF THE MEDICAL DEVICE IN QUESTION. THE MANUFACTURER OF THE MEDICAL DEVICE WAS SYFM. A PHOTOGRAPH OF THE DEVICE LABEL HAS BEEN INCLUDED WITH THIS SUBMISSION; SEE THE ATTACHMENT TITLED "DEVICE LABEL". THE MANUFACTURER LOGO AND CONTACT INFORMATION ON THE LABEL IDENTIFY SYFM AS THE MANUFACTURER.
ON JANUARY 2, 2026, DEL MEDICAL RECEIVED A NOTIFICATION OF REPORT 5200980000-2025-8003, WHICH WAS SUBMITTED THROUGH FDA'S MEDSUN PROGRAM. THE REPORT INCORRECTLY IDENTIFIES DEL MEDICAL AS THE MANUFACTURER OF THE DEVICE INVOLVED IN THE CASE. THE SAME EVENT WAS ALREADY REPORTED TO THE FDA BY DEL MEDICAL ON NOV 25, 2025 IN REPORT 0001418964-2025-00001. IN THE EVENT DESCRIBED BY BOTH REPORTS, DEL MEDICAL WAS THE DISTRIBUTOR OF THE MEDICAL DEVICE IN QUESTION. THE MANUFACTURER OF THE MEDICAL DEVICE WAS SYFM. A PHOTOGRAPH OF THE DEVICE LABEL HAS BEEN INCLUDED WITH THIS SUBMISSION; SEE THE ATTACHMENT TITLED "DEVICE LABEL". THE MANUFACTURER LOGO AND CONTACT INFORMATION ON THE LABEL IDENTIFY SYFM AS THE MANUFACTURER.
ON THE DAY OF THE ADVERSE EVENT, THE CLINIC CALLED DEL MEDICAL TECHNICAL SUPPORT TO REPORT THE INCIDENT. THE FIELD SERVICE ENGINEER (INITIAL REPORTER, (B)(6)) WAS DISPATCHED TO THE FACILITY AND VERIFIED THAT THE X-RAY TUBE WAS CALIBRATED TO STOP 12 INCHES ABOVE THE TABLE. HE DID NOT IDENTIFY ANY ISSUES AND CONFIRMED THE SYSTEM WAS FUNCTIONING PROPERLY. HE REPORTED THAT THE X-RAY SYSTEM IS STILL IN USE AT THE CLINIC. DEL MEDICAL (DISTRIBUTOR) SENT INFORMATION OF THE INCIDENT TO THE OFFICIAL CORRESPONDENT, (B)(4) , AND THE US AGENT, (B)(4) , FOR SYFM (MANUFACTURER). THE WARRANTY AGREEMENT FOR THE UNIT ENDED ON MAY 19, 2012 AND HAS NOT SINCE BEEN SERVICED BY DEL MEDICAL.
N/A. THIS SUBMISSION IS A SUPPLEMENTAL REPORT. SEE H11 - ADDITIONAL MANUFACTURER NARRATIVE.
N/A. THIS SUBMISSION IS A SUPPLEMENTAL REPORT. SEE H11 - ADDITIONAL MANUFACTURER NARRATIVE.
AS REPORTED BY THE CLINIC AT WHICH THE INCIDENT OCCURRED, PATIENT WAS LYING SUPINE ON A TABLE TO HAVE IMAGING PERFORMED, A LEFT AXILLARY VIEW SHOULDER. THE MOTORIZED X-RAY TUBE WAS COMMANDED TO DRIVE DOWN VERTICALLY BY THE RADIOLOGY TECHNOLOGIST. THE TECHNOLOGIST CEASED PUSHING THE BUTTON BUT THE X-RAY TUBE CONTINUED TO DRIVE DOWN. THE X-RAY TUBE IMPACTED THE PATIENT'S LEFT KNEE AND LOCKED. THE TECHNOLOGIST DID NOT USE THE EMERGENCY STOP BUTTON AND DID NOT LOWER THE TABLE TO FREE THE PATIENT. THE PATIENT'S KNEE WAS REMOVED FROM BETWEEN THE TABLE AND THE X-RAY TUBE. THE PATIENT RECEIVED FIRST AID CARE IMMEDIATELY. THE PATIENT WAS ABLE TO AMBULATE TO THEIR CAR FOLLOWING THE INCIDENT. THE CLINIC WAS CONTACTED ON EIGHT OCCASIONS AND DECLINED TO SHARE INFORMATION ABOUT THE CURRENT STATUS OF THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205545 | SHINYOUNG FOR M CO., LTD. | OVER HEAD TUBE CRANE | ITZ | SHINYOUNG FOR M CO., LTD. | SC-1001 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |