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

Model Number NSLX137S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 09/16/2022

Event Type  Injury  

Event Description

It was reported that post op to the hysterectomy procedure the doctor had a bring back, possibly due to a hematomas.There were patient consequences.

Manufacturer Narrative

Pc-pc-(b)(4).Additional information was requested and the following was obtained: during the original procedure were the vessels skeletonized before sealing or were they taken as a bundle? i was not present for the case, but this group does not generally skeletonize.Were the vessels placed in the central portion of the device when sealed? unknown.When sealing vessels in the original procedure, were they checked to see that a complete seal was achieve? unknown.Were there any hemostasis issues during the initial procedure? unknown.Were there any deficiencies with the device that were noticed during use of device? - no, according to the gyn when was the hematoma identified? post op.During the re-op, was the source of the bleeding identified? i was told they were treated in the or and no other intervention was needed post re-op if yes, was it where the enseal was used? no.What was the total blood loss? unknown.Were any blood transfusions necessary? unknown what is the current status of the patient(s)? discharged without further incident.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.

Manufacturer Narrative

(b)(4).Date sent: 11/10/2022.Additional information was requested and the following was obtained: does the surgeon believe there was an alleged deficiency with the device that led to the post-op hematomas? surgeon commented that she was not sure if it was the device, but does not usually have that issue.

• Brand Name: ENSEAL X1 STRAIGHT 37CM SHAFT
• Type of Device: 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: 15580821
• MDR Text Key: 301555469
• Report Number: 3005075853-2022-06809
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015482
• UDI-Public: 10705036015482
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLX137S
• Device Catalogue Number: NSLX137S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2022
• 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