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

Model Number NSLG2S35A

Device Problems Difficult or Delayed Activation (2577); Material Integrity Problem (2978); Appropriate Term/Code Not Available (3191)

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

Event Date 04/06/2023

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure there was a quality issue.

Manufacturer Narrative

(b)(4).Date sent: 5/30/2023.Batch #: x9581u.Additional information was requested and the following was obtained: did the generator display any error messages and if so what were they? no.Did the device pass the pre-test? yes.Had the device been working and then stopped? yes the device stopped shutting and cutting correctly.Did the electrode ceramic separate or break off? no.Did the i blade get damaged or break off? the blade would not advance to cut.Is the jaw damaged but not broken off? yes the jaw wasn't shutting all the way but was not broken.Is the top jaw loose but not detached? yes it was loose and not detached.Is the top jaw ptc material damaged? i do not believe so but don't remember.Is the black ptc in the upper jaw detached? not that i remember.Is the top jaw broken off the of the device? no it was not broken off.Did the patient experience any adverse consequences due to this issue? no we noticed before it was used on the patient again.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 top of the i-blade fractured and slightly lifted.The device was connected to the generator and it was recognized.Because the i blade was damaged not all functional testing could be performed with the generator.The jaws were found attached to the instrument.In addition, no pieces were found missing under microscope inspection.The condition of the blade prevented the functionality of the jaw.The jaw was unable to cycle open and close.A probable cause of the damage to the i blade 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.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 x9581u, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

• 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17025022
• MDR Text Key: 317049327
• Report Number: 3005075853-2023-03599
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLG2S35A
• Device Catalogue Number: NSLG2S35A
• Device Lot Number: X9588Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR