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

Catalog Number	NSLX137S
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 9/25/2024.B3: event year only reported: 2024.D4 batch #: unknown.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Additional information was requested and the following was obtained: what was the indication of the original procedure? endoscopically unresectable polyp/high grade dysplasia.What was the anatomical structure(s) the device was used on? ileocolic pedical.If it was a vessel, what was the approximate size of the vessel? 6mm or less.Did the surgeon note there was a good seal during the original procedure or were there issues intra-op? yes.Were there any hemostasis issues intra-op? no.Were there any generator alert screens during the original procedure? no.Can the surgeon confirm that they received the completion tone with each energy activation? yes.Were there any patient factors (such as chemo treatment, hypertension medication, etc) that could have affected sealing? none.How was the post-op bleeding identified? when she became hypotensive on pod 2, ct scan noted massive hemoperitoneum.What was the total amount of blood loss? over 6 liters.Was a re-operation completed? yes, emergent.What was observed during the re-operation (if applicable)? massive hemoperitoneum.High ligated ileocolic pedicle, widely patent and bleeding.Was the enseal used at the origin site of the bleeding? yes how was the post-op bleeding addressed? 2-0 vicryl tie off.What is the patient¿s current status? she survived after massive transfusion protocol, 3 weeks in icu and 1 month of rehab.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 after a colon resection the patient had a post-op bleed three days after the case.It didn't even look like there was a seal.Patient consequences unknown.

• Brand Name: ENSEAL X1 STRAIGHT 37CM SHAFT
• Common Device Name: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): JABIL (TAJUANA)
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 20300527
• Report Number: 3005075853-2024-07228
• Device Sequence Number: 15385019
• Product Code: GEI
• UDI-Device Identifier: 10705036015482
• UDI-Public: 10705036015482
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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 Catalogue Number: NSLX137S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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