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

Catalog Number 72200568

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a procedure, the device would not power on.The procedure was completed with a competitor's device.No patient injury or complications were reported.

• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5763009
• MDR Text Key: 49279545
• Report Number: 1643264-2016-00105
• 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
• Report Date: 06/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2016
• Date Device Manufactured: 01/02/2015
• 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