MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS PKG, VISUM LED 2 SURGICAL LIGHT, CAMERA READY; LIGHT, SURGICAL, CEILING MOUNTED

Model Number	0682001253
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that in or 7 the visum ll light head had allegedly come off the spring arm.The field service technician (fst) investigated and found that the light had separated from the cardanic arm and not the spring arm as was originally reported.Further investigation revealed that the circlip that is used to secure the cardanic arm to the light head was missing.A quote for a replacement light head was provided to the customer and purchase is pending.Potential reasons for the missing circlip include improper maintenance by the hospital, as the site does perform some maintenance themselves, or improper assembly during the manufacturing process.There was no patient involvement or adverse consequence reported.The investigation is still ongoing, if any further information is found, a supplemental will be filed.
Event or Problem Description
It was reported that the or 7 light came off of the spring arm.There were no reported injuries or adverse consequences.

• Brand Name: PKG, VISUM LED 2 SURGICAL LIGHT, CAMERA READY
• 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: 16523220
• Report Number: 0002031963-2023-00001
• Device Sequence Number: 2393561
• Product Code: FSY
• UDI-Device Identifier: 07613327054347
• UDI-Public: 07613327054347
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 03/10/2023

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 Model Number: 0682001253
• Device Catalogue Number: 0682001253
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 03/10/2023
• 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