MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 CURVED 25CM SHAFT; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number NSLX125C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fistula (1862)

Event Date 03/31/2022

Event Type  Injury  

Event Description

It was reported that, after unknown procedure, pulmonary fistula occurred in (b)(6) 2022.Additional treatment was performed.The patient fully recovered in (b)(6).The patient was discharged from the hospital in (b)(6).No further information is available.

Manufacturer Narrative

(b)(4).Batch #: unknown.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: is there a relationship between the device and there pulmonary fistula? if so, please define the relationship.Additional information was requested and the following was obtained: what was the indication for the surgery? lung carcinoma.What tissue or vessel was the device used on? adhesions removed or divided (upper leaf and mediastinum)/ bronchial artery.Did the user experience any alert screens while using the device? no further information will be available.Were there any device issues intra-operative? o, the device was working correctly.Can more information about the pulmonary fistula be specified, such as location? we did not obtain the information from the surgeon.When did the fistula occur in relation to the original surgery? (b)(6).What was the specific treatment that was given to the patient? we did not obtain the information from the surgeon.What is the patient's current status? the patient was discharged from the hospital on (b)(6).No further information will be provided.An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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: 6/29/2022.Additional information was requested and the following was obtained: is there a relationship between the device and there pulmonary fistula? if so, please define the relationship.=> the surgeon said this is one of common complications and there is no relationhip with the device and pulmonary fistula.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Brand Name: ENSEAL X1 CURVED 25CM 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: orla o'mahony ; 475 calle c; guaynabo
• MDR Report Key: 14775607
• MDR Text Key: 294512827
• Report Number: 3005075853-2022-04038
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015444
• UDI-Public: 10705036015444
• Combination Product (y/n): N
• 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: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLX125C
• Device Catalogue Number: NSLX125C
• Device Lot Number: V95N57
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention