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

Catalog Number 72200568

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/1901

Event Type  malfunction  

Event Description

It was reported that during procedure, device was not recognized.There was no delay reported and no back device available.No patient injury or other complications were reported.

Manufacturer Narrative

The device 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.Complaint of device not being recognized was confirmed.Light source failed power up.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 investigation has concluded the cause of the failure to be a defective electronic component.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.

• 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 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 8349431
• MDR Text Key: 136611781
• Report Number: 1643264-2019-00113
• Device Sequence Number: 1
• Product Code: FFS
• UDI-Device Identifier: 03596010643070
• UDI-Public: 03596010643070
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2019

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 Catalogue Number: 72200568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 03/19/2019
• Supplement Dates FDA Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1