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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG SINGLE USE PAPER FILTER WITH INDICATOR STERILE TECHNOLOGY

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AESCULAP AG SINGLE USE PAPER FILTER WITH INDICATOR STERILE TECHNOLOGY Back to Search Results
Model Number JK095
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation on-going. Additional information / investigation results will be provided in a supplemental report. Manufacturing site evaluation: this is a preliminary report. Only photos are available for the investigation from quality management and the products were sent to the manufacturer for an analysis. Investigation - there were visible holes in the filter. Batch history review - the device quality and manufacturing history records have been checked for the lot number and found to be according to the specifications valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause - only photos are available and it is hardly possible to determine an exact conclusion and root cause. We assume that the cause of the failure is not product related. There is the possibility that the root cause of the problem is most probably usage related. Rationale - this report will be updated when we receive a statement from the manufacturer. According to the quality standard and dhr files a material defect and production error can be excluded. Due to a similar error pattern in other complaints, there is the possibility that the holes were created mechanically by an object or by faulty handling.
 
Event Description
It was reported that there was an issue with a couple single use paper filters. It was noticed that the filter paper in an instrument container had small holes, and the set was rejected due to concern about sterility. When reviewing the rest of the batch, it was possible to verify that there were more filters with the same defect which were not used. It was noted that the malfunction with the set was found prior to a procedure in the safety clinic and the scheduled surgery was postponed. On 21jan2019 additional clarification was received. It was confirmed that the procedure had not yet started, the patient was not under anesthesia, and there was no surgical delay. This report refers to the filter in the surgical instrument set: 9610612-2019-00048.
 
Manufacturer Narrative
(b)(4). Exemption number: e2014018. No known patient history. Pma/510k: k944864: reported device not marketed in the u. S. , however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u. S.
 
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Brand NameSINGLE USE PAPER FILTER WITH INDICATOR
Type of DeviceSTERILE TECHNOLOGY
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
MDR Report Key8290694
MDR Text Key136922199
Report Number9610612-2019-00023
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJK095
Device Catalogue NumberJK095
Device Lot Number4509477053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2019
Was the Report Sent to FDA?
Distributor Facility Aware Date01/09/2019
Device Age9 MO
Event Location No Information
Date Manufacturer Received01/31/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/30/2019 Patient Sequence Number: 1
Treatment
INSTRUMENT CONTAINER
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