MAUDE Adverse Event Report: AESCULAP AG DISP.TROCAR W.DILATING PIN 10/110MM; ACCESS / TROCARS

Model Number EK224SU

Device Problem Material Rupture (1546)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with a disp.Trocar w.Dilating pin.According to the complaint description: "during the use of the puncture device, the front end of the puncture device ruptured, causing puncture of the patient's lung." the surgery was delayed for one hour.The patient's lung lobes were punctured, the bleeding was relatively much, which was treated with haemostatic poweder to stop the bleeding.There was no life threatening situation.A second operation was carried out and a competitor trocar was used instead.The hospital stay was prolonged for 3 days and the recovery was relatively slow.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing evaluation: the product is not available for investigation, but pictures provided by the customer.Failure description - the fractured trocar is not available for investigation, but pictures provided by the customer.Investigation - according to the provided picture, the trocar is fractured at the distal end.A product safety case has already been initiated and several tests and investigations have been performed, (psc #17-05).Batch history review - the device quality and manufacturing history records have been checked for the available lot number 52518568 and found to be according to our specifications valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause - based on the information available it is not possible to determine one possible root cause of the failure, we assume a manufacturing, a design related or a combination of multiple factors.Rationale - psc 17-05 and capa 700003326.Corrective action - psc 17-05 and capa 700003326.

• Brand Name: DISP.TROCAR W.DILATING PIN 10/110MM
• Type of Device: ACCESS / TROCARS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9240904
• MDR Text Key: 166530609
• Report Number: 9610612-2019-00733
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K101937
• 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

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EK224SU
• Device Catalogue Number: EK224SU
• Device Lot Number: 52518568
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention