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

Catalog Number 72200568

Device Problem Inadequate Lighting (2957)

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

Event Date 12/27/2016

Event Type  malfunction  

Event Description

It was reported that during the shoulder procedure, the light source went out.A competitor's back-up was used to complete the procedure.

Manufacturer Narrative

Complaint of shutting down was confirmed.Product overheated due to dead ballast fan.Cause of fan malfunction is a defective mcu pcb.Unit passes functional testing and fans perform as expected with a known good mcu pcb installed.After the evaluation the root cause for the reported issue was defective electronic components.A review of the device history record was performed which confirmed no inconsistencies.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

• 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; austin, TX 78735 ; 5123585706
• MDR Report Key: 6292957
• MDR Text Key: 66510516
• Report Number: 1643264-2017-00063
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

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: 01/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 02/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2015
• 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