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

Model Number	F628
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
(event 1) aggregated events: (b)(6) 2026: deep dive result: or (operating room) #1 being closed for a week from (b)(6) 2026 through (b)(6) 2026.During the week htm (healthcare technology management) had only observed two small cracks on the side by the handle of stryker surgical boom light covers, htm was observing them twice a day for the week with no change when i last checked them on friday (b)(6) 2026.When htm checked the light cover on tuesday morning at 8am there were additional cracks, pls.See the attached pictures that htm took on friday and then ones htm took on tuesday.Or was closed x 1 week for this experiment with the approval of chief of surgery.Htm was told nobody used the room, ems did not clean the room, so there was no other human interaction with the lights or equipment in the room.Based on our experiment it leads me to believe that the plastic is either not good quality, or the covers do not fit correctly causing too much stress and then the covers to crack.(event 2) (b)(6) 2026: nursing observed in or#5 and inor#8 there are broken light covers.This is after ems has changed to the stryker approved cleaning solutions.Htm went to inspect the covers and in or#5 the light cover (ee 153893) was replaced on (b)(6) 2026 and has only been cleaned with the approved solution.Htm reached out to stryker asking for further investigate because at this point we have been following all the stryker recommendations and the light covers are still cracking.(event 3) (b)(6) 2025: upon arriving into operating room (or)# 3, rn discovered that two of the operating room lights had developed cracks in the light head covers that had just been installed as replacements for cracked covers.Rn went to the other 8 operating rooms and found the same thing beginning to happen in 3 other rooms to at least one light each.All of these light head covers are brand new covers that were installed in the (b)(6) of 2025 by stryker as replacements to badly cracked ones.All of the cracks are originating from the same general location on the cover, which is a 3¿5-inch area where the light head joins with the swivel end joint of the light boom arm.> problem: stryker boom light covers compromised integrity related to cracks >product use: operating room surgical procedures.Pt code: 4582.Device codes: 1135, 1069.Reference reports: mw5184964, mw5184965, mw5184966, mw5184967, mw5184969, mw5184970, mw5184971.

• Brand Name: STRYKER BOOM LIGHT COVER
• Common Device Name: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): STRYKER COMMUNICATIONS, INC.
• MDR Report Key: 24557835
• Report Number: MW5184968
• Device Sequence Number: 9500021
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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
• Operator of Device: Health Professional
• Device Model Number: F628
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 12 MO
• Patient Sex: Unknown