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

Catalog Number 72200568S

Device Problem Overheating of Device (1437)

Patient Problem No Information (3190)

Event Date 07/30/2015

Event Type  malfunction  

Event Description

It was reported the device was overheating.

• Brand Name: SVCE REPL, 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: jim gonzales ; 7000 w. william cannon dr.; austin, TX 78735
• MDR Report Key: 6975954
• MDR Text Key: 90863617
• Report Number: 1643264-2017-01016
• Device Sequence Number: 1
• Product Code: FFS
• Combination Product (y/n): N
• PMA/PMN Number: K994084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/25/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 72200568S
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse