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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG BOTTOM FOR 1/1 CONTAINER HEIGHT:90MM STERILIZATION CONTAINERS

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AESCULAP AG BOTTOM FOR 1/1 CONTAINER HEIGHT:90MM STERILIZATION CONTAINERS Back to Search Results
Model Number JK440
Device Problem Residue After Decontamination (2325)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2021
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 jk440 - bottom for 1/1 container height:90mm. According to the complaint description, the silver metallic and black particles were noticed at the bottom of the instrument trays after the steam sterilization cycle. And in the chamber of the units. There was signifiant surgery delay, but it was found in sterile processing before the start of the operation. Additional information was not provided. Additional patient information is not available. The malfunction is filed under aag reference (b)(4). Involved components: jk489 - full-size lid w/retention plate silver - lot unknown. Jf949 - silicone cushioning pad 1/1 size - lot unknown. Jm020 - extra long mini cont. Lid non anodized - lot unknown. Jm021 - extra long mini cont. Bottom non anodized - lot unknown.
 
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Brand NameBOTTOM FOR 1/1 CONTAINER HEIGHT:90MM
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 Key12542955
MDR Text Key273682358
Report Number9610612-2021-00642
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 Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJK440
Device Catalogue NumberJK440
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/25/2021
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/28/2021 Patient Sequence Number: 1
Treatment
JF949 - LOT UNKNOWN; JK489 - LOT UNKNOWN; JM020 - LOT UNKNOWN; JM021 - LOT UNKNOWN
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