MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 CURVED JAW 35CM; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number NSLG2C35

Device Problems Difficult or Delayed Activation (2577); Activation, Positioning or Separation Problem (2906)

Patient Problems No Code Available (3191); Insufficient Information (4580)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: r94f87.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.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: what is the surgeon¿s experience with the device? where the tissue was sticking on the jaw, which side? what troubleshooting steps were taken to address the sticking of the tissue prior to the conversion to open? were there any other laproscopic or cut and coagulate devices available for use prior to the conversion? was the reason to convert solely due to the sticking tissue or was there other issues factors contributing to the decision such as difficult patient anatomy? what procedure was being performed? how were the jaws cleaned when the tissue would stick to the device? a manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during an unknown procedure a large amount of tissue stuck to the jaw of the enseal (tissue pad).This happened since the beginning of the procedure and often in the first 30 minutes of use.The patient had a lot of abdominal fat which resulted in even more tissue adherence in the jaw.Sometimes, even open, the clamp remained adhered to the tissue.This made it difficult for the surgery to progress and the clamp to be removed from the cavity.Due to such difficulty in using the clamp, it was not possible to continue the video surgery and it had to be converted.The patient also had recurrent adhesions from previous procedures.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 12/4/2020.Additional information was requested and the following was obtained: where the tissue was sticking on the jaw, which side? r: em todos os lados do dispositivo.¿ in all sides of the device.What troubleshooting steps were taken to address the sticking of the tissue prior to the conversion to open? r: limpeza frequente.¿ frequent cleaning.Were there any other laparoscopic or cut and coagulate devices available for use prior to the conversion? r: não.- no.Was the reason to convert solely due to the sticking tissue or was there other issues factors contributing to the decision such as difficult patient anatomy? r: o cirurgião apresenta o dispositivo como motivo da conversão, porém a assessora presente em sala relata também anatomia difícil.- the surgeon presents the device as a reason for conversion, but the assistant present in the room also reports difficult anatomy.What procedure was being performed? r: colectomia direita.¿ right colectomy.How were the jaws cleaned when the tissue would stick to the device? r: gase úmida.¿ wet gauze.

• Brand Name: ENSEAL G2 CURVED JAW 35CM
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10619167
• MDR Text Key: 209578505
• Report Number: 3005075853-2020-05110
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036014140
• UDI-Public: 10705036014140
• Combination Product (y/n): N
• PMA/PMN Number: K112033
• 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: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: NSLG2C35
• Device Catalogue Number: NSLG2C35
• Device Lot Number: R94F87
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Patient Sequence Number: 1
• Treatment: GENERATOR; GENERATOR
• Patient Outcome(s): Required Intervention