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

Model Number NSLX137C

Device Problems Difficult to Open or Close (2921); No Apparent Adverse Event (3189)

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

Event Date 01/12/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: unknown.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.Photo images were received and are pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 laparoscopic prostatectomy, the jaws didn¿t open when grasping the handle.The handle also became not to return.The device was replaced tearing off in the state of grasping the target tissue.Although there was a small amount of bleeding when it was torn off, it was not serious and there was no problem with the patient¿s postoperative course.The bleeding was stopped by bipolar.Gen11 was used.Another device was used to complete the case.No further information is available.

Manufacturer Narrative

Pc-(b)(4).Date sent: 3/1/2023 d4 batch #: x94l5c this is an analysis of a set of images submitted for evaluation.Image 1: the image provided by the customer shows a distal jaw of what appears to be an enseal device.The jaws were closed and dried body fluid could be observed.Image 2: the image provided by the customer shows a distal jaw of what appears to be an enseal device.The jaws were open and dried body fluid could be observed.Based on the photo, the reported event was not confirmed.However, no conclusion could be reached as to how this issue occurred through photo analysis.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 determined that the device was returned with the distal guide weld broken.Upon visual inspection, of the device, it was observed that the active rod wire was broken at the distal guide area.The device was tested on the generator, this resulted in the ¿close jaws on tissue and reactivate¿ alert screen, which is advising the generator cannot deliver energy.Then the "replace instrument" screen would be displayed after receiving the "close jaws on tissue and reactivate" message three times.Therefore, we were unable to investigate further the hemostasis controllable issues reported a manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.It is possible that the damage found at the distal guide could have caused the jaw-opening issues reported.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: 16283060
• MDR Text Key: 309125793
• Report Number: 3005075853-2023-00714
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015468
• UDI-Public: 10705036015468
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• 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: X94L5C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR