MAUDE Adverse Event Report: DUO HEADLIGHT 2 BAY SYSTEM - AU; PFM05

Catalog Number 90620AU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Headache (1880)

Event Date 08/18/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the surgeons find that the duo headlight 2 bay system (90620au) was too uncomfortable, causing headaches and dents in the forehead.No medical intervention was required.The surgeons experienced the headache once and stopped using the headlight system.There was no patient involvement; thus, no patient injury or surgical delay occurred.

Event Description

N/a.

Manufacturer Narrative

The duo headlight 2 bay system (90620au) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis: evaluation could not duplicate the issue of discomfort.However, it was found that the gears were slipping when the straps are pulled with moderate force.Adjustment due to wear/misalignment has been made to correct this issue.No manufacturing, workmanship, or material deficiency has been identified.Root cause: the returned 90620au headlight passed testing and met specifications.The issue of discomfort could not be duplicated.The reported issue may be the result of customer preference.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: DUO HEADLIGHT 2 BAY SYSTEM - AU
• Type of Device: PFM05
• MDR Report Key: 12445554
• MDR Text Key: 270486851
• Report Number: 2523190-2021-00201
• Device Sequence Number: 1
• Product Code: FSR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90620AU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1