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

Model Number	82-3190
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hakim programmer was returned for evaluation: dhr - the lot met specifications when released.Failure analysis - programmer and transmitter are working properly and there was no fault found.The internal inspection did not confirm the reported problem.The root cause of the issue reported by customer could not be determined as the device worked correctly.
Event or Problem Description
A facility reported a hakim programmer was overheating.Medical staff had to turn it off, wait for the temperature to drop before using it again.

• 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: 15543301
• Report Number: 3013886523-2022-00451
• Device Sequence Number: 5861954
• 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
• Report Date (Section B): 10/05/2022

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: 82-3190
• Device Catalogue Number: 823190
• Device Lot Number: 8673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2009
• 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