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	01/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the or9 light heads is not working and is disconnected.One light head was completely disconnected from the cardanic arm leaving the cables exposed.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 01/31/2025, it was reported that the visum blade lighthead was disconnected from the cardanic arm and hanging from the cabling.Further, it was reported that the cable cover was missing from the end of the cardanic arm.Extensive damage was observed at the cardanic joint, with a web of fractures present and chunks of material missing.This was remedied by replacing the lighthead and cardanic.This identified failure mode does not currently exceed any threshold and will continue to be monitored.The most likely root cause is due to wear and tear, exacerbated by the improper cleaning procedures.
Event or Problem Description
It was reported that the or9 light heads is not working and is disconnected.One light head was completely disconnected from the cardanic arm leaving the cables exposed.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: kimberly lynch ; 571 silveron blvd; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 21496090
• Report Number: 0002031963-2025-00001
• Device Sequence Number: 20773852
• Product Code: FSY
• UDI-Device Identifier: 07613327061178
• UDI-Public: 07613327061178
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/12/2025

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: 01/31/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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