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

MAUDE Adverse Event Report: GYRUS ACMI, INC SHAVER BLADE, 4MM, STRAIGHT, STANDARD, TYPE A, DS, 5/PK

  • 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
 

GYRUS ACMI, INC SHAVER BLADE, 4MM, STRAIGHT, STANDARD, TYPE A, DS, 5/PK Back to Search Results
Model Number SB4000SA
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/24/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device has not yet been received for evaluation. The cause of the issue cannot be determined at this time. If additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported that the device approximately 10 to 15 minutes during the endoscopic sinus surgery (ess) procedure, the blade axis broke in the nasal cavity. According to the reporter, the subject device was replaced with the same similar device and the intended procedure was completed with no harm or impact to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSHAVER BLADE, 4MM, STRAIGHT, STANDARD, TYPE A, DS, 5/PK
Type of DeviceSHAVER BLADE
Manufacturer (Section D)
GYRUS ACMI, INC
136 turnpike road
southborough MA 01772
Manufacturer Contact
kenneth pittman
118 turnpike road
southborough, MA 01772
9013785969
MDR Report Key10311070
MDR Text Key201873338
Report Number1037007-2020-00024
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT-EQJ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSB4000SA
Device Lot NumberNC801099
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/05/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-