MAUDE Adverse Event Report: AESCULAP AG DISP.TROCAR THRD.W.DILATING PIN 10/110MM; LAPAROSCOPIC SURGERY

Model Number EK226SU

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2019

Event Type  malfunction  

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 the trocar.It was reported that the puncture process was smooth, but the tip of the puncture tube was broken suddenly during the operation.There was no patient harm.Additional information was not provided nor available / was not available.The adverse malfunction is filed under (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: we received a complaint about a broken disposable trocar.The product is not available for investigation.Investigation: the product is not available for investigation but according to the information received, we assume that it is an already known fracture error.A product safety case has already been initiated and several tests and investigations have been performed, details see in psc #17-05.Batch history review: the device quality and manufacturing history records have been checked for the available lot number 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: a psc and capa had been created.Corrective action: a psc and capa had been created.Also new information has been added to b5: details of procedure and date of operation.

Event Description

New information has been received on 02/11/2020: 1.The procedure was a thyroid surgery.2.Regarding remains in the patient: almost everything was taken out of the patient.But there's no way to know for sure if there's any left over.3.The operation was delayed for more than 15 minutes.4.The surgery actually took place on (b)(6) 2019.-> therefore b3 has been edited.

• Brand Name: DISP.TROCAR THRD.W.DILATING PIN 10/110MM
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9477031
• MDR Text Key: 179420521
• Report Number: 9610612-2019-00875
• 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: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: EK226SU
• Device Catalogue Number: EK226SU
• Device Lot Number: 52478800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1