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 07/06/2019

Event Type  malfunction  

Event Description

It was reported that during an acl procedure device shut off and no back-up device was available, a delay of more than one hour was reported.No patient injuries reported.

Manufacturer Narrative

The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.

Manufacturer Narrative

Event description updated.

Event Description

It was reported that during an acl procedure device shut off.Back-up device was requested to the warehouse causing a delay greater than 1 hour.No patient injuries reported.

Manufacturer Narrative

Corrected date of event.

• 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: 9188960
• MDR Text Key: 162973212
• Report Number: 1643264-2019-00690
• 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,Followup,Followup
• Report Date: 11/15/2019

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: 72200568
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 09/25/2019; 11/14/2019; 11/14/2019
• Supplement Dates FDA Received: 10/15/2019; 11/15/2019; 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1