MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE

Model Number	72200568
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that the light source's the device was overheating.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection was performed on the exterior of the device and the lid was not seated correctly, rear lid to case screws were missing, threads for retaining a screw had been stripped and the case scratched.No lamp was returned with the device.A functional test revealed that the lamp fan turns off when the device is in active mode.The fan cables were observed to have been reversed on the sensor board.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.It was determined the device did not contribute to the reported event.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors, unrelated to the manufacturing and design of the device that could have contributed to the reported event, include inadvertently reversing the fan cables resulting in overheating due to the lamp fan shutting down.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: LIGHT SOURCE 500XL XENON
• Common Device Name: IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12714938
• Report Number: 1643264-2021-02381
• Device Sequence Number: 11992082
• Product Code: FFS
• UDI-Device Identifier: 03596010643070
• UDI-Public: 03596010643070
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K994084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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: 72200568
• Device Catalogue Number: 72200568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown