Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE SABER DRILL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
  • 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
 

STRYKER INSTRUMENTS-KALAMAZOO CORE SABER DRILL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE Back to Search Results
Catalog Number 5400120000
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/15/2019
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device overheated during procedure.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
Event or Problem Description
The user facility reported that the device overheated during procedure.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CORE SABER DRILL
Common Device Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key9292103
Report Number0001811755-2019-03693
Device Sequence Number1724353
Product Code ERL
UDI-Device Identifier04546540402011
UDI-Public04546540402011
Combination Product (Y/N)N
Initial Reporter CountryGB
PMA/510(K) Number
112593
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date (Section B) 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number5400120000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2019
Initial Date Received by Manufacturer 10/24/2019
Supplement Date Received by Manufacturer12/27/2019
Initial Report FDA Received Date11/07/2019
Supplement Report FDA Received Date12/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-