MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL X1 LARGE JAW TISSUE SEALER; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Catalog Number NSLX120L

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 9/5/2023.D4 batch unknown.Additional information was requested and the following was obtained: the item that was used was the enseal x1 (large curved) and product # nslx120l.Sorry for the confusion on the terminology as we just finished up a conversion from the ligasure to the enseal devices.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 is the surgeon¿s experience with the enseal device did the surgeon see the device¿s tip (of the jaw) when activating the device during the procedure? what tissue was the device being fired on when the bowel injury occurred? 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.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 Description

See attached medwatch report (b)(4).

Manufacturer Narrative

(b)(4).Date sent: 9/13/2023.Additional information was requested and the following was obtained: ¿ what is the surgeon¿s experience with the enseal device? the physician has used the enseal device before this incident.¿ did the surgeon see the device¿s tip (the jaws of the device) when activating the device during the procedure? yes, the surgeon was focused on the device tip during activation.¿ what tissue was the device being fired on when the bowel injury occurred? physician was drying up the splenic bed.¿ what is the patient's current status? when activating the enseal device, small bowel was punctured by the piece that sticks out between the two handles.Additional surgical intervention to the bowel was required.The patient is in stable condition.

• Brand Name: ENSEAL X1 LARGE JAW TISSUE SEALER
• 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: 17684734
• MDR Text Key: 322672542
• Report Number: 3005075853-2023-06370
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015024
• UDI-Public: 10705036015024
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: NSLX120L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 09/13/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Male