MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number 0682001286

Device Problem Mechanical Problem (1384)

Patient Problem Concussion (2192)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that a light head disengaged from the spring arm.This occurred during a case and it was reported that a nurse went to the er for a possible concussion.The root cause of the issue was missing hardware, likely from an unknown service provider.The light is retained by a safety clip that is held in place by a rotated collar.This collar is held in place by an m3 screw, which utilizes a nut inside the arm.The m3 screw and nut were missing and the collar was raised, no longer covering the safety clip.The safety clip then backed out.The hardware was verified upon installation by stryker and there is no record of service performed or requested for this unit since installation.If any further information is found, a supplemental will be filed.

Event Description

It was reported a light head fell and hit an employee.

• Brand Name: EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): STRYKER-COMMUNICATIONS; 1410 lakeside parkway #100; flower mound TX 75028
• Manufacturer (Section G): STRYKER-COMMUNICATIONS; 1410 lakeside parkway #100; flower mound TX 75028
• Manufacturer Contact: kimberly lynch ; 1410 lakeside parkway #100; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 10726974
• MDR Text Key: 212741111
• Report Number: 0002031963-2020-00003
• 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: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2020

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0682001286
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization