MAUDE Adverse Event Report: CONSOLIDATED MEDICAL EQUIPMENT XENON UNIVERSAL LIGHT SOURCE 300 WATT

Catalog Number LS7700

Device Problem Failure to Reset (1532)

Patient Problem Injury (2348)

Event Date 06/17/2019

Event Type  Injury  

Manufacturer Narrative

The reported device has been returned to conmed and has entered the evaluation process but is not yet completed.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the ls7700, light source failed during a laparoscopic inguinal hernia repair on (b)(6) 2019.The nursing team tried to restart the ls7700 but there was no reaction.The surgeon had to change their approach from laparoscopic to open but otherwise completed the procedure.The patient had an extended hospital stay due to the conversion.This report is being raised as a patient injury due to the extended hospital stay.

Manufacturer Narrative

Complaint is not confirmed.Evaluation of the device could not duplicate the customer complaint.No fault was found after 4 hours of testing however ,the handler was loose, and the lamp was adjusted.Further discussion of the evaluation results with the technician by the mdr specialist and csi revealed that the device functioned as expected when evaluated.The "handler" (handle) used to lock the light source into the device was loose and was tightened and would have no impact on the reported malfunction.Secondly, when questioned about the adjustment of the lamp, the technician indicated that the light output of the device was within test specifications and the adjustment made was to optimize the light output.This is standard procedure when servicing the device and is not a cause for the reported malfunction.The manufacturing documents from the device history record were not reviewed due to the age of the product.The service history record was reviewed, and no data was found.A two-year review of complaint history revealed there has been 20 complaints regarding 20 devices for this device family and failure mode.During the same time frame 58 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be.345 per the instructions for use, the user is advised the following; - ensure all accessories are correctly and completely attached and perform the required preoperative functional tests for the equipment and accessories prior to each use.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: XENON UNIVERSAL LIGHT SOURCE 300 WATT
• Type of Device: LIGHT SOURCE
• Manufacturer (Section D): CONSOLIDATED MEDICAL EQUIPMENT; alejandro dumas ave, 11321; complejo industrial chihuahua; 31136 ; MX 31136
• MDR Report Key: 8786227
• MDR Text Key: 150876849
• Report Number: 3007305485-2019-00227
• Device Sequence Number: 1
• Product Code: GCT
• Combination Product (y/n): N
• PMA/PMN Number: K070376
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LS7700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other