MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS VISUM BLADE LIGHT HEAD ASSEMBLY 5 POLE; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number	P22310
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the or 1 light head detached from the suspension.There were no reported injuries or adverse consequences.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
On 18 jul 2025, it was reported by the account that the visum blade light head had disconnected from the suspension.Multiple attempts were made however, the customer did not place a po for service, so no onsite investigation was performed.It is unclear if the issue was resolved.According to device records, the device was installed and began use in 2016, which exceeds the expected device lifetime of 7 years.The most likely root cause is customer misuse, resulting in material failure and light-head separation.However, this can not be confirmed without onsite investigation.There was no patient impact or harm reported.There were no adverse events reported.This issue does not currently exceed any thresholds and will continue to be monitored.
Event or Problem Description
It was reported that the or 1 light head detached from the suspension.There were no reported injuries or adverse consequences.

• Brand Name: VISUM BLADE LIGHT HEAD ASSEMBLY 5 POLE
• Common Device Name: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): STRYKER-COMMUNICATIONS; 571 silveron blvd; flower mound TX 75028
• Manufacturer (Section G): STRYKER-COMMUNICATIONS; 571 silveron blvd; flower mound TX 75028
• Manufacturer Contact: arsalan rizvi ; 571 silveron blvd; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 22819395
• Report Number: 0002031963-2025-00004
• Device Sequence Number: 5738662
• Product Code: FSY
• UDI-Device Identifier: 07613327061178
• UDI-Public: 07613327061178
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K132747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: Other
• Device Catalogue Number: P22310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown