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

Model Number 90620US

Device Problem Unintended Electrical Shock (4018)

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

Event Type  malfunction  

Manufacturer Narrative

The duo headlight 2 bay system (90620us) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: the depot technician's assessment of the duo headlight found that the unit passed all the tests and checks.No electrical shock registered while testing the unit.Unrelated to the reported complaint, the unit¿s power cord tie wrap was loosening.The tie wrap was replaced to correct this issue.No manufacturing, workmanship, or material deficiency has been identified.Root cause analysis: the duo headlight was returned in used condition with damage to the power cord due to rough handling/environmental damage.The issue of electric shock could not be duplicated.The unit passed electric testing.The damage to the tie wrap would not lead to electric shock.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

A facility reported that the doctor was wearing the duo headlight 2 bay system (90620us) and felt an electrical ¿shock¿.No further information was provided.It is unknown whether there was patient involvement; however, no injury, death or surgical delay was reported.Should additional information become available, a supplemental report will be submitted.

• 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: 14831035
• MDR Text Key: 295063955
• Report Number: 3006697299-2022-00088
• 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: 06/27/2022

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: 03/22/2022
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/27/2022
• 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