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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 CONTAINER LID

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AESCULAP AG FULL-SIZE LID W/RETENTION PLATE SILVER STERILIZATION CONTAINER LID Back to Search Results
Model Number JK489
Device Problem Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: on-going.
 
Event Description
Country of complaint: (b)(6). Filter holder of sterile container fell; the central rivet is twisted. Reported that the product is less than 1 month old and has been used 9 times. Additional components in use: jk479a / upper lid f. 1/1 basic cont/alu silver; jk100 / filter retention plate. Second incident recieved from this end-user. The first is recorded under medwatch report 2916714-2015-01150.
 
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: the products have heavy signs of wear and tear. One of the upper lids has several damages and is deformed, and no longer holds on to the lid. The rivets at the lids are loose and crooked. There are indications of leverage forces recognizable on the upper side of the lids. The retention plate was correctly installed and reconstruction of the loosening of the retention plate is not possible. Based on the information available, as well as the result of the investigation, the root cause of the failure is likely user related. Based on the indications present on the outer side of the lid, a leverage force has been placed on the rivets. Several reasons are possible, for example: improper handling while stacking the lids together, so that other lids are hit on the rivet, bending the rivets and resulting in them becoming loose. Incorrect removal of the retention plate. The plates should be removed by pressing the two buttons on the side of the retention plate at the same time. Without pressing these buttons, a removal of the plate is only possible under high forces. Corrective / preventive action: not applicable.
 
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Brand NameFULL-SIZE LID W/RETENTION PLATE SILVER
Type of DeviceSTERILIZATION CONTAINER LID
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 Key5400184
MDR Text Key37185674
Report Number2916714-2016-00079
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeFR
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 02/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2016
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? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date01/28/2016
Event Location No Information
Date Manufacturer Received11/25/2015
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 Reuse

Patient Treatment Data
Date Received: 01/30/2016 Patient Sequence Number: 1
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