MAUDE Adverse Event Report: LEXION MEDICAL, LLC LEXION 12 MM TROCAR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2020

Event Type  Injury  

Event Description

I was performing a laparoscopic sacrocolpopexy with the lexion trocar system.There were no known problems but at the end of the case before i pulled the trocars, i looked around in the upper abdomen and barely saw what appeared to be a foreign body.I removed this and found it to be a approx.1cm perfectly round piece of grey thin rubber.We pulled the 12mm trocar in that area of the abdomen but it was a sealed trocar so could not tell if it was from it.The lexion rep - brennan was in the procedure and he was very surprised but did think it was the inner seal from his trocar.I told him that he must immediately pull all 12mm trocars until this was evaluated and that he must report this to the fda immediately.I later found out that it was not pulled and other docs were using it.I had a meeting with lexion's head of marketing - (b)(6) and asked her about this.She told me that they were not required to report it and they were re-designing the trocar with a thicker seal and ability to open so i can see if seal was intact at end of case.I have a photo of the old trocar and the piece of seal and can up load that.Fda safety report id# (b)(4).

• Brand Name: LEXION 12 MM TROCAR
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): LEXION MEDICAL, LLC; st. paul MN 55103
• MDR Report Key: 10605986
• MDR Text Key: 209455281
• Report Number: MW5096957
• Device Sequence Number: 1
• Product Code: GCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 65