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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 Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: the device arrived in a decontaminated condition and available for investigation. Lid 1 with 2 retention plates: a visual inspection of the full-size lid with retention plate silver jk489. Here was found visible damage of a deformed cover. Furthermore a visual inspection of the filter retention plates jk100. Both retention plates had visible damage at the internal seal. Both locking bolts show no visible damage. Lid 2 with 2 retention plates: next a visual inspection of the full-size lid with retention plate silver jk4879. Here it was found visible damage. Furthermore a visual inspection of the filter retention plate jk100. A deformation and gaps were found between the retention plate and external seal. Additional a visible damage at the internal seal. The locking bolt shows no visible damage. The product does not require batch management; a review of the device quality and manufacturing history records is not possible. The root cause of the problem is most probably usage related. A capa is not necessary.
 
Event Description
(b)(6). Components in use listed as concomitant deviecs are: jk489 / full-size lid w/retention plate silver (2); jk100 / filter retention plate (2).
 
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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
MDR Report Key7242470
MDR Text Key99093734
Report Number9610612-2018-00041
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K792558
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2018
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 Manufacturer04/04/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date01/18/2018
Event Location No Information
Date Manufacturer Received04/07/2016
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: 02/05/2018 Patient Sequence Number: 1
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