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); Appropriate Term/Code Not Available (3191)

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

Event Date 11/21/2022

Event Type  malfunction  

Event Description

It was reported that, during laparoscopic procedure, the jaws became not to open/close during dissection.It was found that the parts were missing.The missing parts were found in forceps.No pieces fell into the patient.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

(b)(4).Batch#: x94l7c.Additional information was requested and the following was obtained: the event description states "it was found that the parts were missing." please clarify what parts were missing from the device? unknown which part is missing from the device.We will update when we had new information.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 and the manufacturing criteria were met prior to the release of this lot/batch.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.

Manufacturer Narrative

(b)(4).Date sent: 1/17/2023.This is an analysis of a set of images submitted for evaluation.Image eng202202450_1: the image provided by the customer is that of the distal jaw of what appears to be an enseal instrument.A closer look at the clamp arm interface shows the closure slot broken.Image eng202202450_2: the image provided by the customer shows the broken closure slot pieces.Image img_8190: the image provided by the customer shows an enseal device.In addition, a small plastic bag could be observed beside the device.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that the device was received with the upper jaw broken at the closure slot.All pieces were returned with the device.In addition, it was received with the cable cut off.No functional testing could be performed with the generator.The jaws could not close fully.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event.

• 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: 15999496
• MDR Text Key: 308262160
• Report Number: 3005075853-2022-08726
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 20705036015465
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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: X94L7C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR.