MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL 45 CM SHAFT, CURVED JAW; ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES

Model Number NSLX145C

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Failure to Anastomose (1028); Abdominal Pain (1685); Nausea (1970); Confusion/ Disorientation (2553); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: unknown.(b)(4).An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If the product or additional information is received at a later date, the investigation will be updated as applicable.

Event Description

It was reported that during/after a gastro-intestinal procedure clinical trial that the patient experienced nausea, confusion, abdominal pain, ileus, and anastomotic leak.

Manufacturer Narrative

(b)(4).Date sent: 9/2/2021.Additional information was requested and the following was obtained: adverse event term: abdominal pain; outcome: "recovered/resolved;" severity value: "moderate;" relationship to study device: not related; relationship to primary study procedure: not related.Adverse event term: nausea; outcome: "recovered/resolved;" severity value: "moderate;" relationship to study device: "not related;" relationship to primary study procedure: "causal relationship." adverse event term: ileus; outcome: "recovered/resolved;" severity: "moderate;" relationship to study device: "not related;" relationship to primary study procedure: "causal relationship." adverse event term: anastomotic leak; severity: severe; outcome: ¿recovered/resolved;" relationship to study device: not related; relationship to primary study procedure: not related.Adverse event term: confusion; severity: mild; outcome: recovered/resolved; relationship to study device: not related.Relationship to primary study procedure: causal relationship 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: ENSEAL 45 CM SHAFT, CURVED JAW
• Type of Device: ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 12377574
• MDR Text Key: 268476087
• Report Number: 3005075853-2021-05035
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036015499
• UDI-Public: 10705036015499
• 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
• Type of Report: Initial,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NSLX145C
• Device Catalogue Number: NSLX145C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2021
• Patient Sequence Number: 1
• Treatment: GENERATOR.; GENERATOR
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR