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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMER; HAKIM PROGRAMMING TOOLS
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INTEGRA LIFESCIENCES SWITZERLAND SAR HAKIM PROGRAMMER; HAKIM PROGRAMMING TOOLS Back to Search Results
Catalog Number 823190
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.No known patient injury and delay in procedure.
 
Event Description
N/a.
 
Manufacturer Narrative
The programmer was returned for evaluation: review of the history device records for the lot crgb9d sn (b)(6), conformed to the specifications when released to stock failure analysis: inspection did not confirm the reported issue but error message displayed.Device has been reset, checked and returned to customer.The possible root cause of the error message may occurred if the transmitter is disconnected during the self test.
 
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Brand Name
HAKIM PROGRAMMER
Type of Device
HAKIM PROGRAMMING TOOLS
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
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MDR Report Key10775979
MDR Text Key214348109
Report Number3014334038-2020-00082
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 company representative,user f
Type of Report Initial,Followup
Report Date 03/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number823190
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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