MAUDE Adverse Event Report: NOVATECH S.A. NOVATEC TIP; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 109001T

Device Problems Leak/Splash (1354); Connection Problem (2900)

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

Event Date 10/11/2022

Event Type  malfunction  

Event Description

Surgeon requested three vials of sterile talc suspension to use during a thoracic case.When attempting to attach the bulb applicator to the vial, it would not snap on correctly and leaked talc out of the system.Multiple attempts were made to properly attach the applicator and all were unsuccessful.We tried three different bulb applicators.Surgeon was apply to apply the talc using another method.There was no harm to the patient.Product info: steri talc 3g, ref : 62327-333-03, and novatec tip, ref: 109001t.Fda safety report id# (b)(4).

• Brand Name: NOVATEC TIP
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): NOVATECH S.A.
• MDR Report Key: 15753795
• MDR Text Key: 303304553
• Report Number: MW5113111
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/03/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 109001T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2022
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White