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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM VALVE PROGRAMMER ROHS; HAKIM PROGRAMMING TOOLS
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INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM VALVE PROGRAMMER ROHS; HAKIM PROGRAMMING TOOLS Back to Search Results
Catalog Number 823190R
Device Problem Overheating of Device (1437)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported the hakim programmer continuously over heats and wont let you select a setting.
 
Manufacturer Narrative
The hakim programmer was returned for evaluation: device history record (dhr) - the lot met specifications when released.Failure analysis - the internal inspection did not confirm the reported issue as no failure was identified.Inspection has no reported error message issue or any other issue.Device has been reset, checked and returned to customer.No root cause could be determined as the programmer works normally.However, the possible root cause for this issue reported by the customer could be due a technical problem of the system.
 
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Brand Name
HAKIM VALVE PROGRAMMER ROHS
Type of Device
HAKIM PROGRAMMING TOOLS
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
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MDR Report Key10788629
MDR Text Key214781057
Report Number3013886523-2020-00177
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K003564
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number823190R
Device Lot Number131437
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2021
Date Manufacturer Received02/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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