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

Model Number 90600

Device Problem Connection Problem (2900)

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

Event Date 03/21/2023

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 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.

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
• 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: 16745266
• MDR Text Key: 313360266
• Report Number: 3006697299-2023-00041
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 05/23/2023
• 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