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

Catalog Number 72200568

Device Problem Inadequate Lighting (2957)

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

Event Date 08/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

During an arthroscopy procedure it was reported that the light source stopped working in between the surgery.No injuries or procedural complications were reported and the procedure was completed successfully with another device.

Manufacturer Narrative

Evaluation narrative - one 500xl light source part number 72200568 was received on september 04, 2015 and confirmed to be serial number (b)(4).Complaint of power up failure was confirmed.Cause of power failure is a defective power supply/ballast.Unit powered up and passed functional testing with a known good power supply installed.Product was shipped to customer new on (b)(6) 2015.The complaint investigation has concluded the cause of the failure to be a defective electronic component.No corrective actions are recommended at this time.All post market surveillance data will be monitored going forward.(b)(4).

• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5053362
• MDR Text Key: 25644848
• Report Number: 1643264-2015-00149
• Device Sequence Number: 1
• Product Code: FFS
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K994084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/13/2015

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
• Device Lot Number: BBR5537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/13/2015
• Initial Date FDA Received: 09/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2015
• 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