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

Catalog Number NSLG2S35A

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

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

Event Date 07/21/2023

Event Type  malfunction  

Event Description

It was reported that during a gyn procedure the tip broke off.New device was used to complete.No fragments made.No patient harm.

Manufacturer Narrative

(b)(4).Date sent: 9/7/2023.D4 batch #: x95k7g.Investigation summary the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that the device was returned with the upper jaw detached and it was returned.Additionally, it was received with the top of the i-blade fractured and lifted.The device was received with the skiving of the heat shrink (shaft cover) material.All of the heat shrink material appeared to have been returned.The device was connected to the generator and it was recognized.Because the jaw was detached not all functional testing could be performed with the generator.A probable cause of the damage to the jaw could be not allowing thick and fibrous tissues to denature prior to i-blade advancement.As described in the ifu: do not use excessive force on the closing handle to close the jaws; grasp only as much tissue as will fit between the jaws where the current will pass.Greater amounts of tissue require more closing handle force.Excessive force could damage the device.Please reference the instruction for use for more information.The ifu warns "prior to inserting or removing the device from the trocar, ensure that the device is in the straight, non-articulated position by confirming that the indicator arrow on the articulation wheel is aligned with the top of the instrument." the ifu also warns the user to discontinue use if black heat shrink covering is damaged.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch x95k7g, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 10/2/2023.Additional information was obtained: user facility medwatch mw5145055 attached to file h6: medical device problem code.

• Brand Name: ENSEAL G2 ART STRA 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: 17701488
• MDR Text Key: 322874003
• Report Number: 3005075853-2023-06449
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036014515
• UDI-Public: 10705036014515
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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 Catalogue Number: NSLG2S35A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR