MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. DUO HEADLIGHT 2 BAY SYSTEM - US; PFM05

Model Number 90620US

Device Problem Electrical Shorting (2926)

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

Event Type  malfunction  

Event Description

It was reported that pool evaluation of the duo headlight 2 bay system (90620us) was needed.No specific fault was reported.It is unknown whether there was patient involvement; however, no patient injury, death or surgical delay was reported.After the device was returned by the customer, evaluation indicates that there was a short at the end of the power cord.

Manufacturer Narrative

The duo headlight (90620us) was received by the manufacturer¿s service and repair depot: failure analysis: the depot technician assessment found that the fan inside the unit shuts off/on whenever the end of the power cord was moved, indicating a short at the end of the cord.The power cord was replaced to correct this issue.No other issues were found with this loaner unit.Root cause analysis: the returned duo headlight was received in used condition with a shorted power cable due to rough handling/environmental damage.The reported complaint was confirmed.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

Manufacturer Narrative

The duo headlight (90620us) was received by the manufacturer¿s service and repair depot: failure analysis: the depot technician assessment found that the fan inside the unit shuts off/on whenever the end of the power cord was moved, indicating a short at the end of the cord.The power cord was replaced to correct this issue.No other issues were found with this loaner unit.Root cause analysis: the returned duo headlight was received in used condition with a shorted power cable due to rough handling/environmental damage.The reported complaint was confirmed.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

Event Description

It was reported that pool evaluation of the duo headlight 2 bay system (90620us) was needed.No specific fault was reported.It is unknown whether there was patient involvement; however, no patient injury, death or surgical delay was reported.After the device was returned by the customer, evaluation indicates that there was a short at the end of the power cord.

• Brand Name: DUO HEADLIGHT 2 BAY SYSTEM - US
• Type of Device: PFM05
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13020546
• MDR Text Key: 285351415
• Report Number: 3006697299-2021-00071
• Device Sequence Number: 1
• Product Code: FSR
• UDI-Device Identifier: 10381780490746
• UDI-Public: 10381780490746
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2021

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 Model Number: 90620US
• Device Catalogue Number: 90620US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/16/2021
• 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