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

Catalog Number 90620US

Device Problem Electrical Shorting (2926)

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

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 the luminaire of the duo headlight 2 bay system (90620us) has a short in it.It is unknown whether there was patient involvement; however, no patient injury or surgical delay has been reported.

Manufacturer Narrative

Duo headlight (90620us) was returned for evaluation.Failure analysis: the tie wrap on the grommet is detach from the headset; a new tie wrap has been installed on the grommet to correct this issue.No other issues were found with this unit.Root cause: the returned 90620us headlight is in used condition with damage to the cable tie wrap due to rough handling or environmental damage.The reported complaint is confirmed.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• Brand Name: DUO HEADLIGHT 2 BAY SYSTEM - US
• Type of Device: PFM05
• MDR Report Key: 12619465
• MDR Text Key: 277759432
• Report Number: 2523190-2021-00221
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

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: 90620US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 11/03/2021
• 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