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

Model Number NSLX137C

Device Problem No Apparent Adverse Event (3189)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: unknown.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 bmi of the patient? how was the surgeon in-serviced? what device did the surgeon use prior to starting to use the enseal x1 curve jaw? were there any generator alert screens in the original procedure? did the surgeon receive the closing latch click with each energy application in the original procedure? did the surgeon receive the completion tone on each energy application? did the surgeon seal 1 time or multiple times prior to cutting? was any bleeding experienced during the initial operation with the enseal? was the source of the bleeding identified? were any additional procedures performed? if so, what? what was the medical and/or surgical intervention to address the bleeding for this case (1st patient)? 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 Description

It was reported that, during a hysterectomy, the uterus was a little large, not sure why thought this could potentially be adenomyosis.The patient went home next day no problem.However the patient was admitted 2 weeks after with some bleeding and a little anemic and had to be given a blood transfusion.There was a collection of blood pooling.Can¿t say that this was the device but is the first time the physician has had a patient admitted.Patient is fine now but a little shaken up.

• Brand Name: ENSEAL X1 CURVED 37CM SHAFT
• Type of Device: 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: orla o'mahony ; 475 calle c; guaynabo ; *
• MDR Report Key: 14286555
• MDR Text Key: 290776088
• Report Number: 3005075853-2022-02846
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015468
• UDI-Public: 10705036015468
• Combination Product (y/n): N
• PMA/PMN Number: K172580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLX137C
• Device Catalogue Number: NSLX137C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention