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

Model Number	NSLG2S35
Medical Device Problem Codes	Device Alarm System (1012); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during laparoscopic hysterectomy procedure the device jaws were closed they would not reopen.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 7/7/2023 b3: event year only reported: 2023 d4 batch #: unknown additional information was obtained: an internal rapid response call was held on (b)(6)2023 to discuss the g2 straight jaw issues a customer was experiencing.The generator has not been updated to the newest version of the software.When they switched back to g2 after trialing x1, they started seeing some issues.It started with not taking large bites, latching, advancing the blade but then the end effector wouldn¿t open.They would need two hands to pry the device open.There were a few repositioning of the instrument alert tones.The surgeon was not taking big bites, but she would do a double burn.They¿d advance the blade during the first burn, leave the blade out, then cycle the device for a 2nd burn, and then retract the blade after the 2nd burn was completed.The rep noticed there was a lot of built-up tissue in the joint of the jaws.He asked them to remove it, which they struggled with but ultimately got it removed.The alerts went away after the cleaning.The issue was the opening issues with the device and the overall quality.They also indicated that they would get the reposition alert a few minutes before the device would lock close.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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.

• Brand Name: ENSEAL G2 STRAIGHT JAW 35CM
• Common Device Name: 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: 17278467
• Report Number: 3005075853-2023-04727
• Device Sequence Number: 5173436
• Product Code: GEI
• UDI-Device Identifier: 10705036014188
• UDI-Public: 10705036014188
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: NSLG2S35
• Device Catalogue Number: NSLG2S35
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERAOTR
• Patient Sex: Unknown