MAUDE Adverse Event Report: STERIS CORPORATION STERIS OVERHEAD LIGHT; LAMP, SURGICAL

Device Problems Break (1069); Mechanics Altered (2984); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2022

Event Type  malfunction  

Event Description

When the surgical tech reached for the lights to adjust to get ready for surgery the joint gave way and the light came crashing down to the floor.Pieces of the casing fell on the employee's forehead.Fda safety report id# (b)(4).

• Brand Name: STERIS OVERHEAD LIGHT
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): STERIS CORPORATION
• MDR Report Key: 15183545
• MDR Text Key: 297513235
• Report Number: MW5111309
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1