MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LIGHT SOURCE 500XL XENON; LIGHT, SURGICAL, FLOOR STANDING

Model Number 72200568

Device Problems Failure to Power Up (1476); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during a knee procedure, the power of the light source was cut off suddenly, it showed an e13 error code and a fan at the back did not worked.The procedure was successfully completed without significant delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the device and the reported incident.A review of the customer supplied photograph and video was performed and error code e13 was observed.The device will automatically turn off power to the lamp when an e13 error code is observed.The complaint was confirmed and the root cause was associated with component failure.Factors, unrelated to the manufacturing and design of the device that could have contributed to the reported event, include a ballast or other electrical component failure.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.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.

• Brand Name: LIGHT SOURCE 500XL XENON
• Type of Device: LIGHT, SURGICAL, FLOOR STANDING
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 11262728
• MDR Text Key: 229867250
• Report Number: 1643264-2021-00363
• Device Sequence Number: 1
• Product Code: FSS
• UDI-Device Identifier: 03596010643070
• UDI-Public: 03596010643070
• Combination Product (y/n): N
• PMA/PMN Number: K994084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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
• Device Operator: Health Professional
• Device Model Number: 72200568
• Device Catalogue Number: 72200568
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 02/22/2021
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1