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

Catalog Number UNK_ENSEAL X1 TISSUE SEALER LA

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

Patient Problem Urinary Tract Infection (2120)

Event Date 02/18/2021

Event Type  Injury  

Event Description

It was reported during a cystectomy clinical trial eng_2020_03 the patient experienced a urinary tract infection.The severity was moderate and was treated with drug therapy.The patient has recovered.

Manufacturer Narrative

(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: age at the time of surgery: 31-60 years.Where was the device used in the procedure? lower abdomen, urinary tract.The following information was requested, but unavailable: in investigator opinion was there any device deficiency or issue that caused or contributed to the uti? what is the investigator's rational for the possible relationship with the device and the uti? 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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.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.

Manufacturer Narrative

(b)(4).Date sent: 9/13/2022.Additional information was requested and the following was obtained: adverse event term: urinary tract infection 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: where was the device used in the procedure? lower abdomen, urinary tract in investigator opinion was there any device deficiency or issue that caused or contributed to the uti? no.What is the investigator's rational for the possible relationship with the device and the uti? contact with the device to the urinary tract.

• Brand Name: UNK_ENSEAL X1 TISSUE SEALER LARGE JAW
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15195395
• MDR Text Key: 297570796
• Report Number: 3005075853-2022-05184
• Device Sequence Number: 1
• Product Code: GEI
• 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: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ENSEAL X1 TISSUE SEALER LA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 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