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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG BOTTOM FOR 1/1 CONTAINER HEIGHT:120MM CONTAINER BOTTOMS 1/1, 1/2, 3/4, EN

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AESCULAP AG BOTTOM FOR 1/1 CONTAINER HEIGHT:120MM CONTAINER BOTTOMS 1/1, 1/2, 3/4, EN Back to Search Results
Model Number JK441
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 1/1 CONTAINER HEIGHT:120MM
Type of DeviceCONTAINER BOTTOMS 1/1, 1/2, 3/4, EN
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
MDR Report Key7660551
MDR Text Key113185818
Report Number9610612-2018-00288
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
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 NumberJK441
Device Catalogue NumberJK441
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date06/22/2018
Event Location No Information
Date Manufacturer Received06/04/2018
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 Initial

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