MAUDE Adverse Event Report: AESCULAP AG DISP.TROCAR SLEEVE 12/110MM THREAD.W.TAP; LAPAROSCOPIC SURGERY

Model Number EK136SU

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2020

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 product ek136su, disp.Trocar sleeve 12/110mm thread.W.Tap.The tip of trocar was broken in the process of inserting the trocar into the abdomen.Found falling into the field, found all the pieces.There was no patient harm.Additional information was not available.(b)(4).Associated medwatch-reports: 9610612-2020-00239 (b)(4).

Manufacturer Narrative

Investigation results: the device is not available for investigation.A picture of the product involved was provided by the sales organization.According to this picture, the distal end of the disposable trocar ek136su is fractured.Based on the information available, a final root cause could not be determined.There might be a combination of a multiple factors error that leads to the fracture.Based on a very low probability of occurrence the current failure rate lies within the accepted failure rate which is defined in the product risk analysis.Due to similar complaints, additional investigations have been performed.Further measures to improve the product are defined and are still being processed.

Event Description

Associated medwatch-reports: 9610612-2020-00239 (400474920, ek169su).

• Brand Name: DISP.TROCAR SLEEVE 12/110MM THREAD.W.TAP
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10224326
• MDR Text Key: 198728784
• Report Number: 9610612-2020-00238
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EK136SU
• Device Catalogue Number: EK136SU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1