MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number B12LT

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/30/2022

Event Type  Injury  

Event Description

It was reported that during a laparoscopic sacrocolpopexy, subcutaneous emphysema occurred.The trocars used were 2h12lp, b12lt, and two 5mm diameter reusable trocars which are not ethicon products, and a stryker insufflation device.

Manufacturer Narrative

(b)(4).Batch # unk.Additional information was requested and the following was obtained: "the trocars inserted part: umbilicus (2h12lp).The righthand side of the surgeon (b12lt).During the operation, the skin was cut properly, there was no problem in the device.Intraoperative measures were taken to reduce blood co2 concentration by controlling insufflation pressure and flow rate.Postoperatively, subcutaneous emphysema is being followed up.The patient is stable.Comment from surgeon about the cause of subcutaneous emphysema and its relation to trocars: i have had two consecutive subcutaneous emphysema after switching to xcel, when i had been using a balloon port (olympus) and rarely had any.I wonder if there is something in the structure of the xcel that is causing this." attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: "please provide the patients age, gender, weight, and bmi.Were there any issues with the trocar placement prior to insufflation? does the surgeon believe that there is an alleged deficiency with the ethicon device that may have caused or contributed to the complications?" investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.

Manufacturer Narrative

(b)(4).Date sent: 1/4/2023.Additional information was requested and the following was obtained: "-please provide the patients age, gender, weight, and bmi.No further information will be available.-were there any issues with the trocar placement prior to insufflation? no.-does the surgeon believe that there is an alleged deficiency with the ethicon devices that may have caused or contributed to the complications? the patient is stable.Comment from surgeon about the cause of subcutaneous emphysema and its relation to trocars: i have had two consecutive subcutaneous emphysema after switching to xcel, when i had been using a balloon port (olympus) and rarely had any.I wonder if there is something in the structure of the xcel that is causing this.".

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16042346
• MDR Text Key: 306071140
• Report Number: 3005075853-2022-08937
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B12LT
• Device Catalogue Number: B12LT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other