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

Catalog Number 72200568

Device Problem Defective Component (2292)

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

Event Date 05/08/2018

Event Type  malfunction  

Event Description

It was reported that the light output lens is defective.A competitor device was used to complete the procedure.No patient injuries and delay were reported.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.There was no relationship found between the returned device and the reported incident.The complaint of a defective light output lens could not be reproduced.The light output lens (glass rod) was fully functional.Light source did fail for an e-13 error and overheating.Cause of overheating and errors is a defective mcu pcb that control the cooling fans.The cooling for the ballast is activated as soon as the power cord is inserted into the pem and remain activated as long as the power cord is plugged in.The defective mcu pcb shut the cooling fan off when the power button was pressed.Unit passes functional testing and fans perform as expected with a known good mcu pcb installed.The cause of the identified failure is a defective electronic component on the mcu pcb.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: 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: 7532497
• MDR Text Key: 108994081
• Report Number: 1643264-2018-00394
• 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
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

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: BBR9057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 07/06/2018
• Supplement Dates FDA Received: 07/10/2018
• 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