MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 CURVED 37CM SHAFT; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number NSLX137C

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

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

Event Date 02/08/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: did the electrode ceramic separate or break off? it broke at the joint at the top of the shaft.Did the knife get damaged or break off? unknown.Should be clear after examination.Is the jaw damaged but not broken off? it¿s not broken off completely but unusable.Is the jaw loose but not detached? detached.Is the top jaw broken off the of the device? both broken off at the joint "no fragments left inside." 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.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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.

Event Description

It was reported that during a sleeve gastrectomy the jaws of device broke after a lot of activations.A harmonic was opened.The procedure was completed successfully.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 3/22/2023.D4 batch #: v95d1p 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 returned with the distal guide weld broken.In addition, the top jaw is not missing as reported.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 damage to the distal guide was not enough to prevent the jaws to open and closing as expected.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances related to the reported complaint condition were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached on the cause of the reported event.Please refer to the ifu for proper handling of the device, note that ¿caution: do not grasp tissue beyond the electrode surface, in the hinge of the jaws.Do not overfill the jaws of the instrument with tissue.This could result in difficulty opening the jaws, partially cutting tissue, and unintended injury.

• Brand Name: ENSEAL X1 CURVED 37CM SHAFT
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO SURGERY, INC. (CINCINNATI)
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16456441
• MDR Text Key: 310415160
• Report Number: 3005075853-2023-01248
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015468
• UDI-Public: 10705036015468
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K172580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLX137C
• Device Catalogue Number: NSLX137C
• Device Lot Number: V95D1P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR