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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG BOTTOM FOR 3/4 CONTAINER HEIGHT:135MM CONTAINER BOTTOMS 1/1, 1/2, 3/4, EN

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AESCULAP AG BOTTOM FOR 3/4 CONTAINER HEIGHT:135MM CONTAINER BOTTOMS 1/1, 1/2, 3/4, EN Back to Search Results
Model Number JK742
Device Problems Problem with Sterilization (1596); Device Disinfection Or Sterilization Issue (2909)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: usa there is an increasing amount of sets being sent back to spd due to residue found inside container after sterilization. The or staff is doing a "white glove test" - where they will swipe the bottom of the container after removing the basket. After swiping the bottom of the container the or staff (in some cases) are finding a dark residue on glove. No patient injury. Delay in surgery all med watch submissions related to this report are: 9610612-2018-00288, 9610612-2018-00289, 9610612-2018-00290, 9610612-2018-00291, 9610612-2018-00292, 9610612-2018-00296, 9610612-2018-00312.
 
Manufacturer Narrative
Investigation: the components have been examined visually and microscopically with the keyence vhx-5000 digital microscope and a panasonic dmc tz8 digital camera. We made a visible inspection of the lid with retention plate. Here we found visible damages. Conclusion and root cause: the root cause of the problem is most probably usage and design related. Rational: we assume that the damages at the filter retention plate jk100 were caused by improper handling. Corrective action: a product safety case will be initiated.
 
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Brand NameBOTTOM FOR 3/4 CONTAINER HEIGHT:135MM
Type of DeviceCONTAINER BOTTOMS 1/1, 1/2, 3/4, EN
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
MDR Report Key7660581
MDR Text Key113169679
Report Number9610612-2018-00289
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
PMA/PMN Number
K053389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJK742
Device Catalogue NumberJK742
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Distributor Facility Aware Date06/22/2018
Event Location No Information
Date Manufacturer Received06/04/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/03/2018 Patient Sequence Number: 1
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