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

Catalog Number NSLX137C

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 05/10/2022

Event Type  malfunction  

Event Description

It was reported that during a nephrectomy the tweezers stopped seizing the tissue to be coagulated shortly after surgery started, the tweezers worked for 10 minutes.

Manufacturer Narrative

(b)(4).Date sent: 9/29/2023 d4 batch #: v9655k.The following information was requested, but unavailable: did the patient suffer any adverse consequences? 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 jaws broken at the closure slot.Not all pieces were returned with the device.The device was connected to the generator and it was recognized.Because the jaw was damaged not all functional testing could be performed with the generator.The jaws could not close fully.Due to the condition of the device returned we were unable to investigate further the issue reported.A manufacturing record evaluation was performed for the finished device 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 as to what could have caused this issue.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.

• 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: 17845836
• MDR Text Key: 324630156
• Report Number: 3005075853-2023-07036
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015468
• UDI-Public: 10705036015468
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K172580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: NSLX137C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2023
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR.
• Patient Age: 46 YR
• Patient Sex: Male