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

Catalog Number	90600
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that there was a problem with the duo headlight and carrying case (b)(4).The staff reported that the unit began to emit a burnt smell.When the technicians tested the unit, they could not get the light to start at all, although the battery showed a full charge.The technicians also tried connecting the headlight via power cable without success.They suspected that the problem was in the battery and indicated that is where the smell was coming from.The product was not in contact with a patient.No patient injury, death or surgical delay occurred.Final user: (b)(6) hospital.
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.
Additional Manufacturer Narrative
The duo headlight and carrying case (90600) was returned for evaluation: the duo headlight was received in used condition.Evaluation identified that the duo headlight was not working due to the holster.The battery holster was defective, the fan was rattling; the connector board required replacement, and the back gear housing was cracked.The battery holster, connector board, gear back housing and fan have been replaced.Full functional tests were performed according to manufacturer's specification.The issue of this duo headlight having a burning smell is most likely due to overheating caused by damage to the fan.The fan was most likely damaged due to rough handling/environmental damage.The reported complaint was confirmed.No manufacturing, workmanship, or material deficiency has been identified.

• 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: 17079719
• Report Number: 3006697299-2023-00059
• Device Sequence Number: 6273289
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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: Other
• Device Catalogue Number: 90600
• Device Lot Number: L003726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 07/22/2023
• 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