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

Model Number 72200568S

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/1901

Event Type  malfunction  

Event Description

It was reported that the light source had a power failure.No case reported; therefore, there was no patient involvement.

Manufacturer Narrative

The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

The reported device, intended for use in treatment, was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.There was a relationship found between the returned device and the reported incident.The complaint of a power failure was confirmed.The lamp fan did not activate after power up which caused an overheating error and the unit shut down after 10 minute burn-in.Fan malfunction is caused by a defective electronic component.The complaint investigation has concluded the cause of the failure to be a defective electronic component.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.A complaint history review concluded this was a repeat issue.

• 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
• MDR Report Key: 10305000
• MDR Text Key: 199877241
• Report Number: 1643264-2020-00644
• Device Sequence Number: 1
• Product Code: FFS
• UDI-Device Identifier: 03596010650504
• UDI-Public: 03596010650504
• 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,Followup
• Report Date: 09/05/2020

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 Model Number: 72200568S
• Device Catalogue Number: 72200568S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 08/18/2020; 08/18/2020
• Supplement Dates FDA Received: 08/21/2020; 09/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1