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	Hematoma (1884)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date of event: event year only reported.Batch #: unknown.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.What advance energy device does the surgeon typically use? the surgeon typically uses ligasure blunt tip.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 post op to the hysterectomy procedure the doctor had a bring back, possibly due to a hematoma.There were patient consequences.
Additional 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
• 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: 15715806
• Report Number: 3005075853-2022-07499
• Device Sequence Number: 6601505
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 11/10/2022
• 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