MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. ETHICON ENSEAL LARGE JAW TISSUE SEALER; ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Catalog Number NSLX120L

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

Event Type  malfunction  

Event Description

Jaw doesn't meet to seal tissue.No patient harm.Fda safety report id# (b)(4).

• Brand Name: ETHICON ENSEAL LARGE JAW TISSUE SEALER
• Type of Device: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; cincinnati OH 45242 2839
• MDR Report Key: 10343704
• MDR Text Key: 201203096
• Report Number: MW5095793
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: NSLX120L
• Device Lot Number: T94T1H
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR