MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY X-RAY TOP

Device Problem Sharp Edges (4013)

Patient Problem Abrasion (1689)

Event Date 04/27/2022

Event Type  malfunction  

Event Description

The user facility reported that while an employee was handling their x-ray top set to be utilized with their 4085 surgical table, the employee stated the set screws were sharp to the touch and had burrs.The employee obtained a cut and sought medical treatment (general first aid).No procedure delays were reported.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the x-ray top set and found the set screws for the accessory to have rough edges.The technician replaced the set screws, tested the unit, and found it to be operating properly.A complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: X-RAY TOP
• Type of Device: X-RAY TOP
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 14498393
• MDR Text Key: 294759218
• Report Number: 1043572-2022-00039
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1