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

Catalog Number 90620EU

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2021

Event Type  malfunction  

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 during a procedure, the duo headlight (90620eu) fixture moved despite correct touchdown.No adverse event was reported; however, a 30-minute increase of surgery time did occur.

Manufacturer Narrative

The duo headlight was returned for evaluation.The device history record (dhr) - the dhr was reviewed and no anomalies related to the reported failure was observed.Failure analysis: the reported failure could not be confirmed.The headlamp was properly seated and does not move.Maintenance was carried out according to the manufacturer's instructions.The returned headlight passed inspection and testing.No manufacturing, workmanship, or material deficiency has been identified.Root cause: the issue of light fixture moving could not be duplicated.This issue may be the result of customer preference or adjustment error.No further investigation required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.

Event Description

N/a.

• Brand Name: DUO HEADLIGHT 2 BAY SYSTEM - EU
• Type of Device: PFM05
• MDR Report Key: 12369960
• MDR Text Key: 268215910
• Report Number: 2523190-2021-00186
• 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: 10/07/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 90620EU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 09/20/2021
• Supplement Dates FDA Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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