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 Device Embedded In Tissue or Plaque (3165)

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 disp.Trocar.It was reported that during the surgery it was found that the head of trocar had broken and a part was missing.The puncture was noted to have been smooth.Great efforts were made to search for broken parts by endoscope.However, only about 0.3-0.4mm was found and removed.An x-ray was taken via c-arm and images did not reveal the second piece.Additional information was not provided but was requested.The 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.

• 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: 9481246
• MDR Text Key: 179422857
• Report Number: 9610612-2019-00849
• 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: 12/17/2019
• 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: 52478799
• 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
• Patient Age: 43 YR