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

Model Number NSLG2C35A

Device Problems Failure to Read Input Signal (1581); Difficult to Open or Close (2921); Material Integrity Problem (2978)

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

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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 the device got jammed during the advance coagulation.Error message on the generator.At the removal of the device, the sheath was observed damaged.No patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 4/21/2023.D4 batch #: x95h8e.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 the electrode detached from the jaw not returned and active rod is still present on the device.The jaw opens and closes as expected.The device was tested on the generator, this resulted in the ¿close jaws on tissue and reactivate¿ alert screen, this is advising the generator cannot deliver energy.Then the "replace instrument" screen would be displayed after receiving the "close jaws on tissue and reactivate" message three time.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.There is insufficient evidence related to what caused the damage on the device.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: ENSEAL G2 ART CURV SEALER 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: 16613627
• MDR Text Key: 312225006
• Report Number: 3005075853-2023-01930
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036014508
• UDI-Public: 10705036014508
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLG2C35A
• Device Catalogue Number: NSLG2C35A
• Device Lot Number: X95P3G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR.