MAUDE Adverse Event Report: COVIDIEN STEP AUTO SUTURE DILATOR AND CANNULA WITH RADIALLY EXPANDABLE SLEEVE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number S100712

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Impaired Healing (2378); Device Embedded In Tissue or Plaque (3165)

Event Date 08/28/2021

Event Type  Injury  

Event Description

Surgery to remove object; patient had vats procedure to resolve pneumothorax.Was discharged on (b)(6) 2021.Recovery at home did not proceed as expected.Patient returned to er and demanded a ct scan where it was discovered that the covidien step 12mm trocar had broken off in the patient's chest cavity and a 1" piece remained in the cavity after the surgery was completed and patient was discharged.There were other fragments that were embedded in the lung tissue that were discovered during surgery and in a subsequent ct scan, which remain in the patient's lung.Patient experienced numerous symptoms which indicated that there was a post-operative issue remaining.Emergency surgery was performed to remove the piece of trocar and a section of the lung was removed because the trocar was embedded in lung tissue.Patient stayed in the hospital four days on the second visit.Fda safety report id# (b)(4).

• Brand Name: STEP AUTO SUTURE DILATOR AND CANNULA WITH RADIALLY EXPANDABLE SLEEVE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 12513049
• MDR Text Key: 272943937
• Report Number: MW5104130
• Device Sequence Number: 1
• Product Code: GCJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: S100712
• Device Catalogue Number: S100712
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 16 YR
• Patient Weight: 70