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

Catalog Number 90600

Device Problem Overheating of Device (1437)

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

Event Date 04/26/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

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
• Type of Device: 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
• MDR Text Key: 316695150
• Report Number: 3006697299-2023-00059
• Device Sequence Number: 1
• Product Code: FSR
• UDI-Device Identifier: 10381780491064
• UDI-Public: 10381780491064
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: 90600
• Device Lot Number: L003726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 07/22/2023
• 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