MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS VISUM BLADE LIGHT HEAD ASSEMBLY 9 POLE; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number	P22309
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the light head fell off the spring arm.It separated at the spring arm/cardanic connection point.The patient was not yet in the room and no injuries to the staff were reported.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
It was reported at (b)(6) hosp that the light 1 in operating room 4 separated at the spring arm/cardanic connection point.The operating room was been closed and this did not happen during a surgery, there was no patient impact.The retaining clip fell out of the cardanic due to broken endcaps and missing foil tape.The root cause is the cracked/broken endcaps exposing the foil tape and the foil tape falling off at the shaft (causing the clip to fall out).It is unknown how the endcap was cracked but the most probable root cause is due to unapproved cleaning agents over time.The field service technician replaced the light head, cardanic, and endcaps.An unused 9pole visum blade light from operating room 3 was moved into operating room 4.Repair and functionality was then verified.There was no patient or user injury or surgical delay.The sales rep and field service technician have given the customer documents related to cleaning requirements.The lighthead but not the cardanic/springarm was sent back to flower mound for investigation.The lighthead was taken apart for investigation and scrapped after.The lighthead had plastic cracking which was inconclusive to determine root cause.The area of interest at the cardanic/springarm was not able to be investigated.The most probable root cause for the cracked/broken endcaps at the cardanic/spring arm is due to unapproved cleaning agents entering the area over time.If any further information is obtained around this event, a supplemental will be filed.
Event or Problem Description
It was reported that the light head fell off the spring arm.It separated at the spring arm/cardanic connection point.The patient was not yet in the room and no injuries to the staff were reported.There were no reported injuries or adverse consequences.

• Brand Name: VISUM BLADE LIGHT HEAD ASSEMBLY 9 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: 20078810
• Report Number: 0002031963-2024-00004
• Device Sequence Number: 15378374
• Product Code: FSY
• UDI-Device Identifier: 07613327061185
• UDI-Public: 07613327061185
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K132747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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 Catalogue Number: P22309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 11/11/2024
• 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