MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIVERSAL LIGHT GUIDE ORANGE 5MM X 12 FT; ASSAY, SULFHEMOGLOBIN

Model Number	72204925
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the light guide has been displaying a yellow-tone image, in addition the screens indicated the following message "incomplete white balance".There was a surgical delay of more than 30 minutes in the procedure and it was finished with the same faulty device.
Additional Manufacturer Narrative
Internal complaint reference case(b)(4).
Additional Manufacturer Narrative
H10 h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: UNIVERSAL LIGHT GUIDE ORANGE 5MM X 12 FT
• Common Device Name: ASSAY, SULFHEMOGLOBIN
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16045841
• Report Number: 3003604053-2022-00071
• Device Sequence Number: 6220454
• Product Code: GJC
• UDI-Device Identifier: 00885556643747
• UDI-Public: 00885556643747
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K914919
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2024

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 Model Number: 72204925
• Device Catalogue Number: 72204925
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 12/24/2022
• Supplement Report FDA Received Date: 02/25/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown