MAUDE Adverse Event Report: COVIDIEN VERSA ONE OPTICAL TROCAR WITH FIXATION CANNULA; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2020

Event Type  malfunction  

Event Description

During a lap chole procedure after the gallbladder was removed and after the suture passer was used the physician found a small blue piece of plastic in the abdomen and removed it with graspers.The plastic was part of the optical trocar with fixation cannula device.There was no harm to the patient.Fda safety report id# (b)(4.

• Brand Name: VERSA ONE OPTICAL TROCAR WITH FIXATION CANNULA
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10367242
• MDR Text Key: 201932367
• Report Number: MW5095888
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Other
• Patient Age: 24 YR