MAUDE Adverse Event Report: STRYKER COMMUNICATIONS, INC. STRYKER CHROMOPHASE; LIGHT, SURGICAL, CEILING MOUNTED

Model Number F628

Device Problems Loose or Intermittent Connection (1371); Device Fell (4014)

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

Event Date 08/19/2022

Event Type  malfunction  

Event Description

Exam light stryker f628 came loose and fell to floor from spring arm in our operating room #3.No patient in room at the time.Keeper ring and set screw had come loose causing fall.Fda safety report id# (b)(4).

• Brand Name: STRYKER CHROMOPHASE
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): STRYKER COMMUNICATIONS, INC.; flower mound TX
• MDR Report Key: 15293716
• MDR Text Key: 298875210
• Report Number: MW5111715
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1