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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG FILTER RETENTION PLATE ACCESSORIES FOR STERILIZATION

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AESCULAP AG FILTER RETENTION PLATE ACCESSORIES FOR STERILIZATION Back to Search Results
Model Number JK100
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2021
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
 
Event Description
It was reported that there was an issue with jk100 - filter retention plate. According to the complainant, black particles were detected. Hospital says getting micro black flakes which they believe are from basket feet and/or retention plates. The complaint device was returned to the manufacturer for evaluation. There was no described patient harm. Although requested, additional information has not been made available. The malfunction is filed under aag reference (b)(4).
 
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Brand NameFILTER RETENTION PLATE
Type of DeviceACCESSORIES FOR STERILIZATION
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 Key12775548
MDR Text Key280584422
Report Number9610612-2021-00730
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K792558
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJK100
Device Catalogue NumberJK100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/10/2022
Was Device Evaluated by Manufacturer? Yes
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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