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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG DIADUST MIC NDL HDL RD HDL HEAVY 230MM; SPECIALITIES CARDIO-THORACIC S

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AESCULAP AG DIADUST MIC NDL HDL RD HDL HEAVY 230MM; SPECIALITIES CARDIO-THORACIC S Back to Search Results
Model Number FM539R
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 10/09/2019
Event Type  Injury  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information and investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with a needle holder.During the surgery the scissors and the needle holders opened at the hinge during handling; the needle holders did not close and open well, instrument made a creaking noise.The result was a tear of the mammary artery, which the surgeon was able to repair.Nothing fell into the surgical field.An additional medical intervention was necessary.Additional information was not provided nor available.It was unknown whether the instrument was tested prior to use.The adverse event is filed under aag reference (b)(4).
 
Manufacturer Narrative
Manufacturing evaluation: up until now, the product is not available for investigation.Batch history review - the traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack).In addition, the raw materials, semi-finished parts, etc.Used for the order are documented in the manufacturing history records (dhr - device history records).This ensures the traceability of the internal supply and production chain.Internal traceability is thus guaranteed.Conclusion and root cause - based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rationale - without the product, an exact cause cannot be determined at this moment.Based on the quality standard and the device history records, a material or production related error can be excluded.Therefore, we assume the root cause of the error is most probably usage related.According to the quality standard a material defect and production error can be excluded.A usage related error cannot be excluded, e.G.Due to improper handling or an overload situation.If further investigations are required, the product should be provided for examination.According to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action), a capa is not necessary.
 
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Brand Name
DIADUST MIC NDL HDL RD HDL HEAVY 230MM
Type of Device
SPECIALITIES CARDIO-THORACIC S
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM  78501
MDR Report Key9372328
MDR Text Key170080322
Report Number9610612-2019-00786
Device Sequence Number1
Product Code HXK
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFM539R
Device Catalogue NumberFM539R
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/09/2019
Initial Date FDA Received11/25/2019
Supplement Dates Manufacturer Received11/25/2019
Supplement Dates FDA Received12/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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