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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 05/26/2021
Event Type  malfunction  
Manufacturer Narrative
Manufacturer 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 aeculap (b)(4) that a reusable filter for container (part # jk090) was damaged. According to the complainant, the filter was torn. The complaint device has not been returned to the manufacturer for evaluation. No patient involvement. 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 Key12087565
MDR Text Key263241372
Report Number9610612-2021-00457
Device Sequence Number1
Product Code FLE
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 08/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2021
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 Received07/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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