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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUALITY TECH SERVICES LLC NEUROSURGICAL INSTRUMENT/NEXFRAME INSTRUMENT, STEREOTAXIC

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QUALITY TECH SERVICES LLC NEUROSURGICAL INSTRUMENT/NEXFRAME INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number DB-2040
Device Problems Human-Device Interface Problem (2949); Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/30/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the physician found mechanical resistance inserting the lead inside the microguide in 2 of the five holes. The procedure was completed using two of the other holes. No symptoms were reported as a result of the event.
 
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Brand NameNEUROSURGICAL INSTRUMENT/NEXFRAME
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
QUALITY TECH SERVICES LLC
7842 hickory flat highway
suite d
woodstock GA 30188
Manufacturer (Section G)
QUALITY TECH SERVICES LLC
7842 hickory flat highway
suite d
woodstock GA 30188
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key9291398
MDR Text Key174665191
Report Number3012165443-2019-00021
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K012366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2020
Device Model NumberDB-2040
Device Catalogue NumberDB-2040
Device Lot Number082506019A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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