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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 JF949
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: no products at hand. Conclusion and root cause: the root cause of the problem is most probably usage and design relate. Rational: the residues are not related to these products. According to the investigation report from nelson labs: "the infrared scan plot and library search data are included in appendix a. The fourier transform infrared spectroscopy scan has been compared against nelson laboratories, created and commercially available libraries and the five highest matches are provided. The commercial libraries have been produced using the same instrument or may not have been produced using the same method of collection as the original scan. " 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 Key7660577
MDR Text Key113184683
Report Number9610612-2018-00296
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 NumberJF949
Device Catalogue NumberJF949
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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