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

Catalog Number 72200568

Device Problem Insufficient Information (3190)

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

Event Date 11/11/2019

Event Type  malfunction  

Event Description

It was reported that during an acl procedure, the light source shut off.The procedure was successfully completed using a back-up device.There was a delay greater than 30 minutes.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the reported device, used 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 found related failures.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.

• 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
• MDR Report Key: 9428898
• MDR Text Key: 169715775
• Report Number: 1643264-2019-00857
• Device Sequence Number: 1
• Product Code: FFS
• UDI-Device Identifier: 03596010643070
• UDI-Public: 03596010643070
• 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: 01/09/2020

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 Catalogue Number: 72200568
• Device Lot Number: BBR8845
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1