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 Patient Device Interaction Problem (4001)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported clinical trial ((b)(4)) cystectomy the patient experienced a paralytic ileus.  relationship to study device: possibly related.The paralytic ileus required drug therapy.The patient has recovered.

Manufacturer Narrative

(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: when did the ileus occur after initial surgery? = 3 days.Does the investigator believe there was any device malfunction or issue that causes or contributed to the paralytic ileus? = no.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.

Manufacturer Narrative

(b)(4).Date sent: 9/13/2022.Additional information was requested and the following was obtained: 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.

• 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 (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15248703
• MDR Text Key: 298120885
• Report Number: 3005075853-2022-05388
• 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: Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

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 Catalogue Number: UNK_ENSEAL X1 TISSUE SEALER LA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA 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