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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG FILTER RETENTION PLATE STERILIZATION CONTAINERS

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AESCULAP AG FILTER RETENTION PLATE STERILIZATION CONTAINERS Back to Search Results
Model Number JK100
Device Problem Material Erosion (1214)
Patient Problem No Code Available (3191)
Event Date 11/28/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.

 
Event Description

It was reported that there was an issue with a component of the sterile container. Shavings from the filter retention plate were found in the bottom of the tray. The customer is placing different orthopedic sets into the instrument container and on top of the retention plate. The retention plate is perforated and full-size. The customer then transports the container and set to the hospital and feels that the tray is shifting within. As a result of the shifting, it is felt that the tray is shaving small amounts of plastic off the retention plate. Little black particles have being found in the bottom of the tray. This incident caused one surgical procedure to be cancelled (to be confirmed). Further details have been requested but not yet provided.

 
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Brand NameFILTER RETENTION PLATE
Type of DeviceSTERILIZATION CONTAINERS
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 Key8171659
MDR Text Key130621918
Report Number9610612-2018-00598
Device Sequence Number1
Product Code FLE
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK792558
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/17/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberJK100
Device Catalogue NumberJK100
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date01/14/2019
Event Location No Information
Date Manufacturer Received01/14/2019
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 Unkown

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