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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUALITY TECH SERVICES LLC TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL INSTRUMENT, STEREOTAXIC

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QUALITY TECH SERVICES LLC TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733065
Device Problems Imprecision (1307); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2021
Event Type  malfunction  
Manufacturer Narrative
No parts have been received by the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used for a cranial biopsy. It was reported that intra-operatively, an external standard base with a biopsy trajectory guide was installed and an attempt was made to fix the guide stem, but there was no response and it did not hook. There was no choice but to close the locking ring and try to fix it, but the guide stem still lifted and the fixing was insufficient causing misalignment. There was a reported inaccuracy of about four millimeters. The operation was finished by managing to fix the guide stem while holding it by hand. There was no reported impact to patient outcome. There was no reported surgical delay due to this issue.
 
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Brand NameTRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL
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 Key11590593
MDR Text Key244408786
Report Number3012165443-2021-00002
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K971247
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733065
Device Catalogue Number9733065
Device Lot Number066223820
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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