MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD HAKIM PROGRAMMER; HAKIM PROGRAMMING TOOLS

Catalog Number	823190
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported overheating of a hakim programmer.No patient or medical staff impact.
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
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 the hakim programmer was returned for evaluation: dhr - no discrepancies failure analysis - the vpv programmer received with transmitter.Programmer and transmitter are working properly and there was no fault found.The reset, safety and functional test must be performed.The repair, reset, functional and electrical safety test performed.Root cause - the device met specifications.The possible root cause of the error message identified during investigation may occurred if the transmitter is disconnected during the self test or due to mains supply perturbation.Furthermore, the possible root cause of damaged device could be due to a bad handling from the user.

• Brand Name: HAKIM PROGRAMMER
• Common Device Name: HAKIM PROGRAMMING TOOLS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17730245
• Report Number: 3013886523-2023-00309
• Device Sequence Number: 6440732
• Product Code: JXG
• UDI-Device Identifier: 10886704041597
• UDI-Public: 10886704041597
• Combination Product (Y/N): N
• PMA/510(K) Number: K003564
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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 Catalogue Number: 823190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2012
• 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