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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 Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/14/2016
Event Type  malfunction  
Manufacturer Narrative
The components have been examined visually and microscopically with a keyence vhx-5000 digital microscope and a (b)(6). We made a visual inspection of the inlay sheet jk100240. Here we found a bent nose. Additionally we made a visual inspection of the containers lower cover silver jk489200. Here we found bent edges, a visibly damaged edge and other visible damages. Furthermore we found a bent and loose locking bolt jk221224. On the opposite side we found cracks. Additionally, we found a deformed cover. We made a visual inspection of the housing mounted jk100950. Here we found visibly damaged pins and a visibly damaged surface. Additionally when assembling the filter retention plate jk100 at the undamaged locking bolt jk221224. Here we found a gap that is too wide. The root cause of the problem is most probably usage related. We assume that the damages at the inlay sheet jk100240, container lower cover jk489200, locking bolt jk221224 and housing mounted jk100950 were caused by improper handling. There is the possibility that the deformed cover was caused by vacuum damage due to inadequate pressure equalization. The gap between the filter retention plate jk100 and the container lower cover was probably contributed to by the deformed cover. Furthermore, due to the quality standard, a production error or material defect can be excluded. No capa is necessary.
 
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: (b)(6). It was reported that while preparing for a total knee arthroplasty surgery, when opening the cover to use instruments the filter with the holder dropped inside the container. There was a two hour delay in surgery in order to complete a sterilization on the instruments. The procedure was completed without any harm to the patient.
 
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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 Key6029699
MDR Text Key252626685
Report Number2916714-2016-00848
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeJA
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 10/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date09/30/2016
Event Location No Information
Date Manufacturer Received09/15/2016
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

Patient Treatment Data
Date Received: 10/14/2016 Patient Sequence Number: 1
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