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

MAUDE Adverse Event Report: AESCULAP AG REUSABLE FILTER FOR CONTAINER 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 AG REUSABLE FILTER FOR CONTAINER STERILE TECHNOLOGY Back to Search Results
Model Number JK090
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2020
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with jk090 - reusable filter for container. According to the complaint description, the filter were damaged/torn. Mainly, holes or cracks in the central circle are observed. It is difficult to say for sure how many passes these filters have undergone. The average estimate would be 190 passes with a minimum of 12 cycles and a maximum of 600. There was no described patient harm. Additional information was not provided nor available. The malfunction is filed under aag reference (b)(4). Associated medwatch-reports: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREUSABLE FILTER FOR CONTAINER
Type of DeviceSTERILE TECHNOLOGY
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
christian von der grün
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key11015027
MDR Text Key227797116
Report Number9610612-2020-00903
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K792558
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 02/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJK090
Device Catalogue NumberJK090
Device Lot Number4509388010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-