MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. 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 duo headlight (90620us) was shorting out and has exposed wires.It is unknown if there was patient involvement; however, no injury or surgical delay was reported.

Manufacturer Narrative

The duo headlight (90620us) was not returned for evaluation; therefore, an evaluation of the device could not be performed.The root cause(s) of the reported issue could not be determined.However, the issue of shorting out and exposed wires may be the result of damage to the power cord or cord tie wrap.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• 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: 12678183
• MDR Text Key: 278154073
• Report Number: 2523190-2021-00228
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 11/15/2021
• Supplement Dates FDA Received: 11/19/2021
• 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