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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 STERILE TECHNOLOGY

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AESCULAP AG FULL-SIZE LID W/RETENTION PLATE SILVER STERILE TECHNOLOGY Back to Search Results
Model Number JK489
Device Problems Residue After Decontamination (2325); Device Disinfection Or Sterilization Issue (2909)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/02/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: the investigation was carried out visually. The dust in question is not available for investigation, only pictures were provided. The single use paper filter and filter holders are used, but no damage can be found. The container bottoms and lids are also in used condition, several scratches on the surface, but no significant damages can be found. Conclusion and root cause: based on the information available as well as a result of our investigation, the root cause of the failure is most probably user related. Rational: the provided products are all in good condition, thus we exclude a material or manufacturing related error. Furthermore it is very unlikely that such a large amount of dust can get into a properly working container system. It is conceivable that such an amount of impurities can get into a container, if the user has forgotten to install a paper filter before the sterilization process. No capa is necessary.
 
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: (b)(6). It has been reported that fluff (dark in color) was found inside the containers that have been sterilized. Components in use listed as concomitant devices are: jk489 / full-size lid w/retention plate silver. Jk441 / bottom for 1/1 container height:120mm.
 
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Brand NameFULL-SIZE LID W/RETENTION PLATE SILVER
Type of DeviceSTERILE TECHNOLOGY
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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key6754361
MDR Text Key210586848
Report Number9610612-2017-00389
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K053389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2017
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? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date07/24/2017
Event Location No Information
Date Manufacturer Received07/10/2017
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 Initial

Patient Treatment Data
Date Received: 07/31/2017 Patient Sequence Number: 1
Treatment
JK441 / BOTTOM FOR 1/1 CONTAINER HEIGHT:120MM; JK489 / FULL-SIZE LID W/RETENTION PLATE SILVER
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