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

Model Number NSLX120L

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Urinary Tract Infection (2120); Obstruction/Occlusion (2422)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: unknown.Additional information obtained: age range 61-100.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 tissue(s) or vessel(s) was the device used on during the procedure? during the operation was there any device malfunction, deficiency or handling issues? what is the investigator's rational behind the possible device relationship with the e.Faecium in urine and with the paralyticileus? 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

It was reported that after a clinical trial, eng_2020_03, cystectomy the patient experienced detection of e.Faecium in urine and paralytic ileus.The detection of e.Faecium in urine was moderate with a possible relationship to the device and a related relationship with the procedure.It required drug therapy and the patient recovered with sequelae.The paralytic ileus was mild with a possible relationship to the device and a related relationship with the procedure.It required drug therapy and a gastric tube.The patient recovered.

Manufacturer Narrative

Pc-(b)(4).Date sent: 9/13/2022 additional information was requested and the following was obtained: adverse event term: detection of e.Faecium in urine relationship to study device: value "possibly related" has been changed to "not related" adverse event term: paralytic ileus relationship to study device: value "possibly related" has been changed to "not related" upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

Manufacturer Narrative

(b)(4).Date sent: 9/12/2022.Additional information was requested and the following was obtained: what tissue(s) or vessel(s) was the device used on during the procedure? ¿ suspensions of the bladder, urethra underneath the prostate, dissection of the prostate pedicles, incision of the mesentery during the operation was there any device malfunction, deficiency or handling issues? - no what is the investigator's rational behind the possible device relationship with the e.Faecium in urine and with the paralytic ileus?- in general a relation to a paralytic ileus may be possible due to the incision of the mesentery with the enseal-device.

• 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: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15189304
• MDR Text Key: 297487511
• Report Number: 3005075853-2022-05151
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015024
• UDI-Public: 10705036015024
• 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,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2022

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
• Device Operator: Health Professional
• Device Model Number: NSLX120L
• Device Catalogue Number: NSLX120L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 08/15/2022; 09/13/2022
• Supplement Dates FDA Received: 09/12/2022; 09/13/2022
• 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
• Patient Sex: Male