MAUDE Adverse Event Report: ETHICON ENDO-SURGERY INC. ENSEAL DISPOSABLE TISSUE SEALING DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number ETRIO335H

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Enseal not working during activation.Enseal machine read "replace device".Fda safety report id# (b)(4).

• Brand Name: ENSEAL DISPOSABLE TISSUE SEALING DEVICE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY INC.; cincinnati OH 45242 2839
• MDR Report Key: 13168975
• MDR Text Key: 283336680
• Report Number: MW5106454
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10705036000297
• UDI-Public: (01)10705036000297
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: ETRIO335H
• Device Catalogue Number: ETRIO335H
• Device Lot Number: V9697U
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1