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

Model Number 72200568S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/04/2018

Event Type  malfunction  

Event Description

It was reported that light will not stay consistent.No back-up device was available.Nor delay or patient injury reported.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed and no issues were noted.There was a relationship found between the returned device and the reported incident.The complaint of inconsistent light output was confirmed.Cause of inconsistent light output is a worn out lamp.Lamp received with light source has recorded 623 hours of usage.Lamp module should be replaced at 500 hours of usage.Display shows a message of "replace lamp" on power up.Lamp module ignites intermittently on power up and light output is not consistent.Unit passes functional testing with a known good lamp module installed.The complaint investigation has concluded the cause of the failure to be a lamp module that has expired the maximum hours of usage.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

• 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 west william cannon drive; austin, TX 78735
• MDR Report Key: 7553418
• MDR Text Key: 109671850
• Report Number: 1643264-2018-00424
• Device Sequence Number: 1
• Product Code: FFS
• UDI-Device Identifier: 03596010650504
• UDI-Public: (01)03596010650504
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200568S
• Device Catalogue Number: 72200568S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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