MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 CURVED 25CM SHAFT; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number NSLX125C

Device Problems Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: v94187.Additional information was requested and the following was obtained: did the electrode ceramic separate or break off? no further information will available.Did the i blade get damaged or break off? no further information will available.Is the jaw damaged but not broken off? no further information will available.Is the top jaw loose but not detached? no further information will available.Is the top jaw ptc material damaged? no further information will available.Is the black ptc in the upper jaw detached? no further information will available.Is the top jaw broken off the of the device? no further information will available.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 nslx125c device was returned with the electrode slightly delaminated.The device was tested on the generator and passed all functional testing.The energy output delivered from the device was verified.All tones were heard during functional testing.The device was tested with the test media and no anomalies were found.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances related to the reported complaint condition were identified.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reach on the cause of the reported event.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

Event Description

It was reported that, during a thoracoscopic pneumonectomy, the jaw broke during use.The device was used about 5 hours.When the device cut the target tissue, the tissue and the jaw stuck together, and the jaw was pulled to the tissue side.However, the device still functioned properly, the device was used to the end of the operation.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.

• Brand Name: ENSEAL X1 CURVED 25CM SHAFT
• 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, INC. (CINCINNATI)
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 12701614
• MDR Text Key: 278540659
• Report Number: 3005075853-2021-06425
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015444
• UDI-Public: 10705036015444
• Combination Product (y/n): N
• PMA/PMN Number: K172580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2021

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 Model Number: NSLX125C
• Device Catalogue Number: NSLX125C
• Device Lot Number: V94187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR