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

Catalog Number	NSLX137S
Medical Device Problem Code	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: 12/10/2024.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.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 following her right colectomy, and after six days of perfectly straightforward postoperative care, the patient operated on with the trial enseal forceps presented a sudden and significant hemorrhage, which the resuscitator and i (the surgeon) were able to restore by operating extremely rapidly.We found three liters of blood in her belly, and the ileo-caeco-appendicular artery, severed to allow the right colectomy, was bleeding at its stump.This bleeding was very unusual, and occurred at day 6 without explanation.This artery is smaller than an inferior mesenteric artery, which i treat in the same way for left colectomies.In this patient, it was rather smaller, of the order of 5mm.This patient managed to overcome this hemorrhagic shock and is currently convalescing.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/10/2024.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: what was the indication for the colectomy? was any chemotherapy given prior to or after the surgery? was any anti-coagulation medication given to the patient after the surgery? did they encountered any device issues/malfunctions/error messages during the original procedure that would led him/her to believe the device caused this? if yes, can details of the issue be provided? was the device fully latched on each seal? what is the surgeon's experience with the enseal x1 straight jaw device?.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/18/2024 additional information was requested and the following was obtained: the indication was a tumour of the cecum, without lymph node involvement.No chemotherapy was performed.The patient was on lmwh as a postoperative preventive measure, at a dose of 3000ui anti-xa per day.I carried out this thermofusion in the presence of your sales representative (this was a trial).I found that the thermofusion area wasn't as coloured (scorched) and dried out as usual (with another brand of forceps) but she told me that this was normal, that it was less sticky, and the fact is that the fusion went normally, with no abnormal bleeding either intraoperatively or in the first few days.The thermofusion was carried out with application: device locked, thermofusion three times over less than a cm (distal, proximal then section in the middle).I was using this device for the first time, but with confidence.I've been using thermofusion to section colonic arteries for over twenty years (ligasure, ultracision, applied), without any additional haemostasis using clips or sutures (except ultracision), and without ever having had an incident of this type.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/2/2024.Corrected data: d4 udi # and h6 type of investigation.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

• 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
• Manufacturer (Section G): JABIL (TAJUANA)
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 20893804
• Report Number: 3005075853-2024-09337
• Device Sequence Number: 15434067
• Product Code: GEI
• UDI-Device Identifier: 10705036015482
• UDI-Public: (01)10705036015482(17)280131(10)A9C86T
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/10/2024

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 Catalogue Number: NSLX137S
• Device Lot Number: A9C86T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 11/25/2024; 12/12/2024; 12/18/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 12/10/2024; 12/18/2024; 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2023
• 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