MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL 45 CM SHAFT, CURVED JAW; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number	NSLX145C
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Additional information obtained: the surgeon did have a patient that had to come back.The patient with the hematoma did not have a returned device (b)(4).This patient had half the amount of hemoglobin.The patient is doing fine.The bleeding had stopped when they re-operated.The cleaned the area up and couldn¿t find the source of the bleeding.The surgeon did not experience any sticking in any of his procedures.He is also latching with each use 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 or Problem Description
It was reported that during the sleeve gastrectomy procedure, the patient was taken back for an upper abdomen hematoma.The doctor has noticed more bleeding and lack of sealing with the device over the last four to six weeks.Product is used along the greater curvature.Hemoglobin went from 14.4 to 7.7.No active bleeding once they got into the abdomen.Original procedure date was (b)(6) 2023 sleeve gastrectomy.Bring back was (b)(6) 2023.There was no patient consequences.

• Brand Name: ENSEAL 45 CM SHAFT, CURVED JAW
• Common Device Name: 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: 16643582
• Report Number: 3005075853-2023-02095
• Device Sequence Number: 14991609
• Product Code: GEI
• UDI-Device Identifier: 10705036015499
• UDI-Public: 10705036015499
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NSLX145C
• Device Catalogue Number: NSLX145C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown