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

Model Number 72200568

Device Problem Failure to Power Up (1476)

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

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that the power of the main body of light source, 500xl, xenon does not turn on.No case involved.Therefore, there was no patient involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10, h3,h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of product and no physical damage was observed.A functional evaluation revealed a power up failure.The cause of power failure is a defective power supply/ballast.Unit powered up and passed functional testing with a known good power supply installed.The complaint was confirmed and the root cause was associated with component failure.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.

Manufacturer Narrative

Internal complaint reference: (b)(4).H10 h3,h6: the reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.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 manufacturing records found the device has been in service for over 5 years, thus any malfunction presented at this point in time would not be related to the manufacture of the product.A complaint history review concluded this was a repeat issue.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: LIGHT SOURCE 500XL XENON
• Type of Device: IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10915068
• MDR Text Key: 218551372
• Report Number: 1643264-2020-01956
• Device Sequence Number: 1
• Product Code: FFS
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1