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

Model Number EK136SU

Device Problem Structural Problem (2506)

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

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 a trocar.During an unspecified procedure, the cannula was noted to be damaged; it appeared as if melted.According to the staff, a bipolar instrument had also been used during surgery and an "ultra sonic." there was no patient harm.The adverse event/malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

On receipt of the complaint sample it was noted that a different product - contrary to the initially reported product - was involved.The actual product code of the complaint sample is ek136su and was never distributed to the us.Based upon the new state of information this event is deemed not reportable.Product number (received 20sep2019).

• 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: 8922130
• MDR Text Key: 155864815
• Report Number: 9610612-2019-00573
• 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: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• 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?: Yes
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1