MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 LARGE JAW TISSUE SEALER; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number NSLX120L

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)

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

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: r93h2n.Date of event: month of event unknown.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.

Event Description

It was reported that during an unknown demonstration of a sample device the handle was sticking from the beginning and after two or three fires the handle would not open.No patient involvement.

Manufacturer Narrative

(b)(4) date sent: 8/27/2021 investigation summary the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the nslx120l device was returned with no apparent damage.The device was connected to a gen11 and functionality tested.In addition, it was tested with the test media and no anomalies were found.No issues were noted with the opening and closing of the jaws.During analyzed, it was determined that the device was connected to more than one generator.Adaptive tissue technology devices are supplied sterile, single patient use instruments.Using the device on more than one generator is potentially associated with device re-use.Multiple patient use may compromise the device integrity or create a risk of contamination that, may result in patient injury or illness.If the device is connected to a different generator an alert screen will be displayed indicating to replace the instrument / no instrument uses remaining.The device was disassembled to inspect the internal components and no anomalies were noted.This device is packaged and sterilized for single use only.Multiple patient use may compromise the device integrity or create a risk of contamination that, in turn, may result in patient injury or illness.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: ENSEAL X1 LARGE JAW TISSUE SEALER
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 12278503
• MDR Text Key: 265372005
• Report Number: 3005075853-2021-04466
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015024
• UDI-Public: 10705036015024
• Combination Product (y/n): N
• PMA/PMN Number: K172580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: NSLX120L
• Device Catalogue Number: NSLX120L
• Device Lot Number: R93H2N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Date Manufacturer Received: 08/10/2021
• Patient Sequence Number: 1
• Treatment: GENERATOR