MAUDE Adverse Event Report: STERIS CORPORATION; TOP SET

Model Number	X-RAY TABLE TOP
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility personnel stated that the x-ray top set was loose in the box which could have caused damage to the device during shipping and handling.The user facility is scheduled to receive another digital x-ray top set.A 3-year complaint review has considered the reported event to be isolated.No additional issues have been reported.
Event or Problem Description
The user facility reported that their digital x-ray top set arrived dented/damaged and while their biomed technician was handling the device he cut his finger.The user facility declined to provide information about if the biomed technician sought or received medical treatment.

• Brand Name: NA
• Common Device Name: TOP SET
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 25116011
• Report Number: 1043572-2026-00048
• Device Sequence Number: 9292483
• Product Code: FQO
• UDI-Device Identifier: 10724995157668
• UDI-Public: (01)10724995157668
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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
• Operator of Device: Health Professional
• Device Model Number: X-RAY TABLE TOP
• Device Catalogue Number: BF101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown