MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL G2 CURVED JAW 45CM; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number	NSLG2C45
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during kidney and adrenal gland procedure with da vinci, i-blade was broken during use.Broken piece has been retrieved.No pieces fell into the patient.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).Batch #: t9256r.Additional information was requested and the following was obtained: the broken piece was retrieved under the laparoscopic operation.The broken piece will be returning.The patient is stable.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the nslg2c45 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.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.Please reference the instruction for use for more information: as part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.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 kidney and adrenal gland procedure with da vinci, i-blade was broken during use.Broken piece has been retrieved.No pieces fell into the patient.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).Batch #: t9256r.Additional information was requested and the following was obtained: the broken piece was retrieved under the laparoscopic operation.The broken piece will be returning.The patient is stable.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the nslg2c45 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.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.Please reference the instruction for use for more information: as part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4) date sent: 2/2/2022 this is an analysis for a set of images / an image submitted to ethicon endo surgery for evaluation.Image: the image provided by the customer is that of what appears to be an enseal device.No conclusion could be reached as to how this issue occurred through photo analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• Brand Name: ENSEAL G2 CURVED JAW 45CM
• Common Device Name: 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: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13251912
• Report Number: 3005075853-2022-00254
• Device Sequence Number: 17210925
• Product Code: GEI
• UDI-Device Identifier: 10705036014157
• UDI-Public: 10705036014157
• Combination Product (Y/N): N
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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: 12/31/2023
• Device Model Number: NSLG2C45
• Device Catalogue Number: NSLG2C45
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2019
• 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: GENERATOR
• Patient Sex: Unknown