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

Catalog Number NSLG2C35A

Device Problems Failure to Read Input Signal (1581); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/11/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 2/1/2024.D4 batch #: unknown.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: was there any change to the patient¿s post op care due to the 50ml extra blood loss (such as blood products give, etc.)? 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 a lap.Sigmoïd there was an error - occurred to replace instrument.A new device was used after the error.There was a 50ml extra blood loss.

Manufacturer Narrative

(b)(4).Date sent: (b)(6) 2024.Additional information was requested and the following was obtained: was there any change to the patient¿s post op care due to the 50ml extra blood loss (such as blood products give, etc.) this is unknown.

Manufacturer Narrative

(b)(4).Date sent: 4/3/2024.D4 batch #: a9dc0h.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 on the generator and passed all functional testing.The energy output delivered from the device was verified.All three tones were heard during functional testing (tone 1 is heard when the energy activation button is pressed; tone 2 is heard when the tissue impedance threshold is reached and tone 3 is heard when the cycle is complete).The device was tested with the test media and no anomalies were found.There were no anomalies noted with the functionality of the device.No "replace instrument" alert screen was displayed during the test.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device batch a9dc0h, and no non-conformances were identified.

• 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: 18622099
• MDR Text Key: 334316700
• Report Number: 3005075853-2024-00926
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036014508
• UDI-Public: 10705036014508
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K122797
• 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,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NSLG2C35A
• Device Lot Number: A9DD9V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 03/05/2024; 04/01/2024
• Supplement Dates FDA Received: 03/14/2024; 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR.
• Patient Outcome(s): Other