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

MAUDE Adverse Event Report: AESCULAP INC ROUND FILTERS W/INDICATOR STERILE TECHNOLOGY

  • 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
 

AESCULAP INC ROUND FILTERS W/INDICATOR STERILE TECHNOLOGY Back to Search Results
Model Number US751
Device Problem Material Discolored (1170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/05/2019
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report. Investigation on-going.
 
Event Description
It was reported that there was an issue with the round filters. While opening instrument sets prior to surgery, brown spots were found on the filters, which are sterility indicators. The patient was not yet in the operating room or under anesthesia; however, a delay of 5-10 minutes occurred while another tray was opened instead. Additional information was not available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameROUND FILTERS W/INDICATOR
Type of DeviceSTERILE TECHNOLOGY
Manufacturer (Section D)
AESCULAP INC
3773 corporate parkway
center valley PA 18034
Manufacturer (Section G)
AESCULAP INC
3773 corporate parkway
center valley PA 18034
Manufacturer Contact
lindsay chromiak
3773 corporate parkway
center valley, PA 18034
MDR Report Key8588743
MDR Text Key144966951
Report Number2916714-2019-00011
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUS751
Device Catalogue NumberUS751
Device Lot Number1901011
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date03/05/2019
Event Location No Information
Date Manufacturer Received12/04/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-