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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG FULL-SIZE LID W/RETENTION PLATE SILVER STERILIZATION CONTAINERS

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AESCULAP AG FULL-SIZE LID W/RETENTION PLATE SILVER STERILIZATION CONTAINERS Back to Search Results
Model Number JK489
Device Problem Residue After Decontamination (2325)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
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 jk489 - full-size lid w/retention plate silver. According to the complaint description, there was an unknown residue on the lid. Clear glue material was found beside the gasket stuck to lid. There was a delay or 5 mins to retrieve new set. Additional information was not provided. Additional patient information is not available. The malfunction is filed under aag reference (b)(4).
 
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Brand NameFULL-SIZE LID W/RETENTION PLATE SILVER
Type of DeviceSTERILIZATION CONTAINERS
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 Key12510129
MDR Text Key272708876
Report Number9610612-2021-00624
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053389
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
Report Date 09/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJK489
Device Catalogue NumberJK489
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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