MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC A JOHNSON AND JOHNSON CO. TEMPERATURE CONTROLLED TISSUE SEAL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 98002511

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2022

Event Type  malfunction  

Event Description

While using the enseal instrument during exploratory laparoscopy procedure, it was noted by staff that the enseal tip was missing.After thorough search it was found in pieces on the ground.Fda safety report id# (b)(4).

• Brand Name: TEMPERATURE CONTROLLED TISSUE SEAL
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC A JOHNSON AND JOHNSON CO.; guaynabo PR 00969
• MDR Report Key: 14117565
• MDR Text Key: 289443716
• Report Number: MW5109001
• Device Sequence Number: 1
• Product Code: GEI
• 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: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 98002511
• Device Catalogue Number: NSEAL545RH
• Device Lot Number: V95X8T
• 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
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 115 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American