MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) DUO HEADLIGHT AND CARRYING CASE; PFM05

Model Number	90600
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A facility reported that during surgery, there was bad contact between the cable and the battery of the duo headlight and carrying case (90600).The surgery was stopped until the doctor's partner could lend his headlight.It was reported that the surgery was delayed for 30 minutes.There was consequence to the patient.
Additional Manufacturer Narrative
The duo headlight and carrying case (90600) was returned for evaluation.The problem indicated by the customer was confirmed.Evaluation identified that the battery-to-headlight cable was loose and required replacement.The connector board must be replaced as part of the cable replacement.Evaluation also identified that the holster connector was bent and cracked.There was also a rattle coming from the holster.This is most likely due to rough handling/environmental damage.No manufacturing, workmanship, or material deficiency has been identified.The power cord cable, connector board and holster were replaced.The full functional test according to manufacturer's specification have been performed.

• Brand Name: DUO HEADLIGHT AND CARRYING CASE
• Common Device Name: PFM05
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16745266
• Report Number: 3006697299-2023-00041
• Device Sequence Number: 6642350
• Product Code: FSR
• UDI-Device Identifier: 10381780491064
• UDI-Public: 10381780491064
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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
• Operator of Device: Health Professional
• Device Model Number: 90600
• Device Catalogue Number: 90600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown