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

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.

• 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 Key: 9372328
• MDR Text Key: 170080322
• Report Number: 9610612-2019-00786
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Number: FM539R
• Device Catalogue Number: FM539R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention