MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX 60 COMPACT; STAPLE, IMPLANTABLE

Catalog Number	SC60A
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Date sent: 1/5/2023.B3: exact event date unk, entered 1/1/2023 as only the year was provided.D4: batch # unk.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.A manufacturing record evaluation was performed for the finished sc60a, with lot/batch number a9d46h, and no non-conformances were identified.Additional information was requested and the following was obtained: did the device cut? yes it cut, and made a complete but irregular cut line if so, did the device make a complete cut line? yes.Did the device staple? the device did not staple properly.In a tissue that was not thicker if so, did the device deploy the full staple line? yes it deploy them, but i don't close them properly.If staples did deploy, were the staples the appropriate b-form shape? no.If the device did not cut or staple, what were the associated patient consequences? the final consequence is that 24 hours after the patient's surgery, the staples became loose and there was uncontrollable bleeding, which is why the patient had to be taken to a thoracotomy and pulmonary raphia.Please provide a time line of events that led up to the patient's death.The surgeon states that the chronology was what he already stated, what happened in the procedure, and the reintervention.Is there an autopsy report available? no.Is the surgeon interested in speaking with ethicon medical and engineering staff? more than interested in talking, it is to know exactly what happened.Procedure: lobectomy institution: high technology medical institute (imat) patient status: the patient in which the reported devices were used passed away.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
In the procedure, the stapler does not cut the tissue and likewise the reloading does not staple.Was surgery delayed due to the reported event? : unknown, was procedure successfully completed? : unknown, were fragments generated? : unknown, if yes, were they removed easily without additional intervention? : unknown, patient status/ outcome / consequences : no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required : unknown, is the patient part of a clinical study : unknown, (b)(4).Device property of : none, device in possession of : none, (b)(4).Device property of : none, device in possession of : none.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/10/2024.D4: batch # 435c45.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the sc60a device was returned with the anvil bent upwards and with two gst60d (b and c) reloads present.The reload (b) was received fully fired with flash in some drivers and a slight damage on the cartridge deck.The reload (c) was received fully fired as well, and with slight flash in some drivers.Furthermore, the anvil knife slot was noted to be damaged.No functional test was performed due to the condition.In addition, two tyveks were returned along with the reloads.It is possible that the combination of tissue and/or buttressing material compressed between the device jaws may have been beyond the indicated thickness of tissue that cannot compress to the indicated range for the selected cartridge.This may have caused excessive force to be applied to the underside of the solid steel anvil leading to this damage.It should be noted that a 100% inspection takes place during manufacturing to ensure the device meets the required specifications prior to shipments, in addition, a sample of the batch is inspected finished good quality assurance.Please reference the instruction for use for more information.Device history review a manufacturing record evaluation was performed for the finished device batch number 435c45, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: ECHELON FLEX 60 COMPACT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; PR ; 3035526892
• MDR Report Key: 18452910
• Report Number: 3005075853-2024-00089
• Device Sequence Number: 7034003
• Product Code: GDW
• UDI-Device Identifier: 30705036002714
• UDI-Public: 10705036002710
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K081146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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 Expiration Date: 04/30/2026
• Device Catalogue Number: SC60A
• Device Lot Number: A9D46H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GST60D (X2)
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown