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

Model Number NSLG2S35

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

It was reported that during a hemicolectomy at the time of taking tissue in the device does not start the energy cycle.The device is disconnected for a possible failure, it is reconnected and it continues to show the same error.Doctor requests the change of the clamp.The procedure was completed successfully.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 2/2/2023.Batch #: x95j6x.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the device was received with no apparent damage.The device was tested with a generator, the hand activation was not functional.However, the device worked properly with the footswitch.The instrument was disassembled to inspect the internal components and it was noted that one of the hand activation wires was disconnected.This caused the hand activation failure.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached as to what caused this issue.A manufacturing record evaluation was performed for the finished device batch x95j6x, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 2/24/2023.

• Brand Name: ENSEAL G2 STRAIGHT JAW 35CM
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• 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: 16286076
• MDR Text Key: 309154107
• Report Number: 3005075853-2023-00745
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036014188
• UDI-Public: 10705036014188
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K112033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

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
• Device Model Number: NSLG2S35
• Device Catalogue Number: NSLG2S35
• Device Lot Number: X95P3H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/08/2023
• Initial Date FDA Received: 02/02/2023
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR