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

Catalog Number	823190R
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
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
A facility reported the fuses of a hakim valve programmer (823190rp) systematically blows on every start-up.Patient impact not provided.
Additional Manufacturer Narrative
Updated fields: d4 (primary udi#), d9, g3, g6, h2, h3, h6, h11.The hakim valve programmer (823190rp) was returned for evaluation: the internal inspection of the hakim valve programmer did confirm the reported issue of the fuses systematically blowing on every start-up.The possible root cause for the reported issue is likely due to misuse.The unit has been scrapped.
Event or Problem Description
N/a.

• Brand Name: HAKIM VALVE PROGRAMMER ROHS
• Common Device Name: HAKIM PROGRAMMING TOOLS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19537121
• Report Number: 3013886523-2024-00179
• Device Sequence Number: 8337593
• Product Code: JXG
• UDI-Device Identifier: 10381780519317
• UDI-Public: 10381780519317
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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: 823190R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 01/22/2025
• 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