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

Catalog Number 72200568S

Device Problem Insufficient Information (3190)

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

Event Date 08/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during a shoulder surgery, one of the fans was not working.No back up device was available.No delay or patient injuries were reported.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was a relationship found between the returned device and the reported incident.The complaint of fan malfunction was confirmed.The lamp fan fail to function after power up.Then the lamp overheats after a few minutes.Cause of overheating and fan malfunction 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 the cause of the failure to be 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: 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
• MDR Report Key: 9079795
• MDR Text Key: 158954136
• Report Number: 1643264-2019-00646
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

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: 10/01/2019
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 10/22/2019
• Supplement Dates FDA Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1