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

Catalog Number 90620EU

Device Problem Material Integrity Problem (2978)

Patient Problem Headache (1880)

Event Date 05/18/2021

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 operator gets an intense headache during surgery when using the duo headlight (90620eu).The headache is believed to be caused by the fit and/or the inner padding of the headlight.The facility has stated that the coating of the material used as padding is too sleek/slippery, and that to prevent the head light from gliding, it needs to be secured/tightened to the degree where it causes a headache.They further stated that this may be a risk for patient damage.The device was not in contact with a patient, thus there was no patient injury, nor was there increased surgery time.

Manufacturer Narrative

An evaluation of the device could not be performed because the device was not returned.Definitive root cause cannot be determined.The issue of headaches or discomfort may be the result of improper adjustment.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.If the device is later returned, the complaint will be reopened to perform the respective evaluation and document the failure analysis.

Event Description

N/a.

• Brand Name: DUO HEADLIGHT 2 BAY SYSTEM - EU
• Type of Device: PFM05
• MDR Report Key: 12116214
• MDR Text Key: 261708019
• Report Number: 2523190-2021-00144
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90620EU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 07/05/2021
• Supplement Dates Manufacturer Received: 07/22/2021
• Supplement Dates FDA Received: 08/06/2021
• 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