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

Model 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	04/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: n internal rapid response call was held on (b)(6) 2022 to include post market surveillance, customer quality, marketing, design engineering, quality engineering, and local associates to discuss the various issues.There was oozing throughout the case.The surgeon would do double and triple burns, which is the same technique as they use with the ligasure.At the end of the case, the surgeon did get a little bit of a bleeder and it was sealed with the enseal straight jaw.The case was completed.The patient had to be brought back to the or in the middle of the night with a bleeder.The surgeons believe that it was the enseal¿s fault.There is no device to be returned.The bleeding in the procedure seemed to be at the distal tip and the tissue was pretty thick and dense.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 of the surgery? what is the surgeon¿s experience with device? were there any generator alert screens during the procedure? what vessels and structures was the device used on? was the surgeon doing 1 or multiple burns on the main vessels? did the user seal to completion with the end tones with each firing? did the user use the latch mechanism? how was the bleeding identified? when was the bleeding identified in relation to the original procedure? what was the source of the bleed? how was the bleeding addressed? what is the patient's current status? 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.
Event or Problem Description
It was reported that post op bleed to the procedure total lap hysterectomy, the patient came back with a vessel bleed.They used the enseal during the case with little bleeding.It is unknown of the treatment that was used to stop the bleeding.

• 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: orla o'mahony ; 475 calle c; guaynabo ; *
• MDR Report Key: 14322573
• Report Number: 3005075853-2022-02945
• Device Sequence Number: 14736724
• Product Code: GEI
• UDI-Device Identifier: 10705036015482
• UDI-Public: 10705036015482
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2022

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: NSLX137S
• Device Catalogue Number: NSLX137S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/07/2022
• 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