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 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 4/20/2023.B3: event year only reported: 2023.D4 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.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 an unknown procedure the device rachet handle was stuck when it clamped on the vessels.Doctor couldn't open the handle and she needed to tear off the vessels in order to get the jaw out from vessels.Bleeding occurred and she had to open a new enseal.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 5/19/2023.D4 batch #: x9442y.Additional information was requested and the following was obtained: 1.When the jaws of the device was opened after it was removed from the tissue, was it opened outside the patient or inside the patient? ans: opened outside the patient.Even though it was open, but the jaw able to open half only.2.The device was reviewed for analysis and it was found that the sharp end of the knife of the device was not returned.Does the surgeon know what happened to the broken off piece? ans: so far surgeon didn¿t see any broken piece.She said she noticed a piece of something hanging in the jaw after she opened it.And she passed the whole enseal x1 to her scrubbing nurse.After the case, scrubbing nurse cleaned the jaw, called me and asked me to collect for product complaint.It could have dropped somewhere during the transfer or when they cleaned the enseal before they passed it to the sales rep.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 no apparent damage.Upon visual inspection, of the device, it was observed that the distal tip of the knife was broken off.The broken piece was not returned with the device.The device was tested on the generator.The energy output delivered from the device was verified.All tones were heard during functional testing.The device opens and closes the jaws as expected.However, due to the condition of the knife, the device was unable to cut.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.No conclusion could be reached as to what could have caused the issue found.

Manufacturer Narrative

(b)(4).Date sent: 6/15/2023.Additional information was requested and the following was obtained: bleeding occurred, requiring her to open a new enseal.Is the new enseal the same as the stuck one? ans: new enseal works well as expected.2.What is the patient¿s condition? is it fix that the patient did not experience bleeding after using the new enseal? ans: yes, patient doesn¿t experience bleeding after new enseal seals well.3.To confirm, the new enseal used is nslx137c (which is the same product code as the complaint device).Ans: yes.

• 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: 16775963
• MDR Text Key: 313721371
• Report Number: 3005075853-2023-02758
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015468
• UDI-Public: 10705036015468
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K172580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• 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: X9642Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR.