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

Catalog Number 72200568

Device Problem Loss of Power (1475)

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

Event Date 11/10/2016

Event Type  malfunction  

Event Description

It was reported that the 500xl xenon light source shut down during a procedure causing a brief loss of image during a laproscopic cholecystectomy procedure.No delay was reported, and the procedure was completed using a backup device.No patient injury or complications were reported.

Manufacturer Narrative

Complaint of shutting down was confirmed.Product failed when power cord was inserted into pem and ballast fan ran until power button was depressed.Then ballast fan stopped and unit shut down with an e13 error which indicates overheating from a non-functional ballast fan.Unit passes functional testing and fan performs as expected with a known good mcu pcb installed.The complaint investigation has concluded the root cause of the reported failure to be a defective electronic component on the mcu pcb.A review of the device history record was performed which confirmed no inconsistencies.

• Brand Name: LIGHT SOURCE, 500XL, XENON
• Type of Device: ILLUMINATOR, 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 w william cannon dr.; austin, TX 78735 ; 5123585706
• MDR Report Key: 6147634
• MDR Text Key: 61864996
• Report Number: 1643264-2016-00266
• Device Sequence Number: 1
• Product Code: FFS
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2017

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: 11/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1