MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 CURVED JAW 25CM; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number	NSLG2C25
Medical Device Problem Codes	Material Separation (1562); Ambient Noise Problem (2877); Difficult to Open or Close (2921); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #t94f0w.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 and the manufacturing criteria were met prior to the release of this lot/batch.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during semi-open pneumonectomy, at the third or fourth use during a chest wall (muscle) incision, there was an abnormal clicking sound and the jaw no longer opened or closed.The jaw was easily opened manually and removed from the tissue without any tissue damage.The blade broke outside the surgical field and the broken piece was discarded.As a precaution, an x-ray was performed after the operation, but there were no blade found in the patient's body.When the product was used several times, the jaw opened and closed poorly and the product was discontinued and returned to the nurse.Before a thoracotomy, when the tip of the jaw was wiped with gauze, the gauze was caught and the nurse tried to force it, but the tip broke.Gen11 was used.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date: 8/20/20.Investigation summary: the device was received with the top of the i-blade upper tip broken off not returned.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 condition of the blade prevented the functionality of the jaw.The jaw was unable to cycle open and close.No noises were heard at any time during testing.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.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.Additional information was requested, and the following was obtained: to be precise, it was not "the jaw could not be opened" but "the jaw no longer opened or closed".The jaw was easily opened manually and removed from the tissue.No tissue damage.The blade broke outside the surgical field.The broken piece of the blade was discarded.As a precaution, an x-ray was performed after the operation, but there was no blade in the body.The doctor determined that there was no possibility of the blade remaining in the body.The procedure was lung cancer chest wall resection.The product was used during chest wall (muscle) incision.When the product was used several times, the jaw opened and closed poorly and the product was discontinued.It was returned to the nurse.Before the thoracotomy, when the tip of the jaw was wiped with gauze, the gauze was caught and the nurse tried to force it, but the tip was broken.

• Brand Name: ENSEAL G2 CURVED JAW 25CM
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10339343
• Report Number: 3005075853-2020-03880
• Device Sequence Number: 3853970
• Product Code: GEI
• UDI-Device Identifier: 10705036014133
• UDI-Public: 10705036014133
• Combination Product (Y/N): N
• PMA/510(K) Number: K112033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: NSLG2C25
• Device Catalogue Number: NSLG2C25
• Device Lot Number: T94K2M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 08/20/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR; GENERATOR