• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Intracranial Hemorrhage (1891); Unspecified Infection (1930); Pleural Effusion (2010); Renal Failure (2041)
Event Date 03/16/2021
Event Type  Injury  
Manufacturer Narrative
This value is the average age of the patients reported in the article as specific patients could not be identified. Patient gender is the majority value of patients in the study. Patient weight not available from the site. Event date is the online publish date of the publication. Device lot number, or serial number, unavailable. 510(k) is dependent upon field d4 and is, therefore, unavailable. No parts have been received by the manufacturer for evaluation. Device manufacture date is dependent on the device lot/serial number, therefore is unavailable. If information is provided in the future, a supplemental report will be issued.
Event Description
Citation: alon orlev, gil kimchi, liat oxman, idan levitan, david felzenstein, nentanel ben shalom, shani berkowitz, ido ben zvi, yosek laviv, giorgio rubin, uzi ben david, sagi harnof. Minimally invasive intracerebral hematoma evacuation using a novel cost-effective tubular retractor: single-center experience. World neurosurg. (2021) 150:42-53. Https://doi. Org/10. 1016/j. Wneu. 2021. 03. 083 background: spontaneous intracerebral hematoma (ich) is a common disease with a dismal overall prognosis. Recent development of minimally invasive ich evacuation techniques has shown promising results. Commercially available tubular retractors are commonly used for minimally invasive ich evacuation yet are globally unavailable. Methods: a novel u. S. $7 cost-effective, off-the-shelf, atraumatic tubular retractor for minimally invasive intracranial surgery is described. Patients with acute spontaneous ich underwent microsurgical tubular retractoreassisted minimally invasive ich evacuation using the novel retractor. Patient outcome was retrospectively analyzed and compared with open surgery and with commercial tubular retractors. Results: ten adult patients with spontaneous supratentoria ich and median preoperative glasgow coma scale score of 10 were included. Ich involved the frontal lobe, parietal lobe, occipitotemporal region, and solely basal ganglia in 3, 3, 2, and 2 patients, respectively. Mean preoperative ich volume was 80 ml. Mean residual hematoma volume was 8. 7 ml and mean volumetric hematoma reduction was 91% (median, 94%). Seven patients (70%) underwent >90% volumetric hematoma reduction. The total median length of hospitalization was 26 days. On discharge, the median glasgow coma scale score was 12. 5 (mean, 11. 7). Thirty to 90 days' follow-up data were available for 9 patients (90%). The mean follow-up modified rankin scale score was 3. 7 and 5 patients (56%) had a modified rankin scale score of 3. Conclusions: the novel cost-effective tubular retractor and microsurgical technique offer a safe and effective method for minimally invasive ich evacuation. Cost-effective tubular retractors may continue to present a valid alternative to commercial tubular retractors. Reported events: 1) 72 year old patient experienced a second spontaneous ich anatomically unrelated and it was noted that the ich resolved spontaneo usly 2) 76 year old patient experienced a subdural effusion with no mass effect that was noted to resolve spontaneously 3) 60 year old patient experienced seizures and vap that were resolved with tx 4) 44 year old patient experienced a cns infection that was resolved withtx 5) 68 year old patient experienced a cns infection that was resolved with tx 6) 48 year old patient experienced renal failure, cap and seizures that were resolved with tx 7) 42 year old patient experienced a cns infection that was resolved with tx 8) 71 year old patient experienced a suspected infected cerebral fluid collection that underwent subsequent debridement.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key12617202
MDR Text Key276408416
Report Number1723170-2021-02484
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK_NAV_SYS
Device Catalogue NumberUNK_NAV_SYS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/12/2021 Patient Sequence Number: 1