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

Catalog Number 72200568S

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

It was reported the bulb casing melted around the bulb on the lightsource.This occurred before a procedure.No delays or patient injuries were reported.

Manufacturer Narrative

Device investigation narrative - complaint of overheating was confirmed.Unit shuts down after 10 minute warm up because cooling fan for lamp is not activated upon lamp ignition.Cause of lamp cooling fan failure is a defective mcu pcb.Unit passes functional testing and fans perform as expected with a known good mcu pcb installed.The complaint investigation has concluded that this unit has succumbed to expected wear and tear since unit is over 3 and a half years old.

• Brand Name: SVCE REPL, 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 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 6186176
• MDR Text Key: 63104800
• Report Number: 1643264-2016-00293
• Device Sequence Number: 1
• Product Code: FFS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K994084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

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: 72200568S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2013
• 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