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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG REUSABLE FILTER FOR CONTAINER DISPOSABLES CONTAINER SYSTEM

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AESCULAP AG REUSABLE FILTER FOR CONTAINER DISPOSABLES CONTAINER SYSTEM Back to Search Results
Model Number JK090
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2021
Event Type  malfunction  
Manufacturer Narrative
Manufacturing evaluation: investigation on-going. Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
 
Event Description
It was reported to aesculap ag that a reusable filter for container (part # jk090) was used during a procedure performed on (b)(6) 2021. According to the complainant, the filters appears torn at the base, in the center. No patient complications were reported as a result of this event. Although requested, additional information has not been made available. The malfunction is filed under aag reference (b)(4).
 
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Brand NameREUSABLE FILTER FOR CONTAINER
Type of DeviceDISPOSABLES CONTAINER SYSTEM
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 Key11890449
MDR Text Key265654345
Report Number9610612-2021-00412
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K041623
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 06/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJK090
Device Catalogue NumberJK090
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 Received05/28/2021
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 Unkown

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