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

Model Number NSLX137C

Device Problems Material Separation (1562); Material Integrity Problem (2978); Insufficient Information (3190)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 7/21/2023.B3: event year only reported: 2023.D4 batch #: unknown.Additional information was requested and the following was obtained: did the generator display any error messages and if so what were they? unknown.Did the device pass the pre-test? yes.Had the device been working and then stopped? yes.Did the electrode ceramic separate or break off? yes; separated.Did the i blade get damaged or break off? yes.Is the jaw damaged but not broken off? yes.Is the top jaw loose but not detached? yes.Is the top jaw ptc material damaged? yes.Is the black ptc in the upper jaw detached? no.Is the top jaw broken off the of the device? no.Did the electrode ceramic separate or break off? yes.Did the knife get damaged or break off? no.Is the jaw damaged but not broken off? yes.Is the jaw loose but not detached? yes.Is the top jaw broken off the of the device? not completely.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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 unknown procedure the jaws the device fell apart.Unknown if the procedure was completed successfully.There were no patient consequences.

• 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO SURGERY, INC. (CINCINNATI)
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17370347
• MDR Text Key: 319486622
• Report Number: 3005075853-2023-05159
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015468
• UDI-Public: 10705036015468
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2023

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: NSLX137C
• Device Catalogue Number: NSLX137C
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR