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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 Failure To Adhere Or Bond (1031)
Patient Problem Missing Value Reason (3192)
Event Date 02/02/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Additional 510(k) / procode: k792558 / (b)(4). Manufacturing site evaluation: on-going.
 
Event Description
Country of complaint: (b)(6). Upon opening of sterilized container for orthopedic procedure, it was noticed that the filter holder had fallen into the container; sterility could not be assured. Additional instrument set had to be obtained which resulted in delay of approximately 30 minutes with patient under anesthesia. Additional component involved: jk100 / filter retention plate - medwatch report filed on this component : 2916714-2016-00194.
 
Manufacturer Narrative
During surgery the container was opened and the customer realized that the filter holder has fallen into the container. So sterility was not sure. The container lid is in a used condition, several scratches are visible. The retention plates are also used, but no severe damage can be identified. The products were analyzed visually and several function test were carried out. The product does not require batch management; a review of the device quality and manufacturing history records is not possible. Based on the information available as well as a result of our investigation the root cause of the failure is most probably user related. Recreated the described error, but the retention plates, so we can exclude a production or material caused error. Most likely the retention plate was not assembled probably during the mounting. According to sop sa-de13-m-4-2-01-010 a capa is not necessary. The current failure rate is within the risk analysis and therefore acceptable.
 
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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 Key5493706
MDR Text Key40120182
Report Number2916714-2016-00155
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 03/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2016
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 Date02/25/2016
Event Location No Information
Date Manufacturer Received02/09/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/10/2016 Patient Sequence Number: 1
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