MAUDE Adverse Event Report: COVIDIEN LP VERSASTEP PLUS DILATOR AND CANNULA WITH RADIALLY EXPANDABLE SLEEVE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number VS101015P

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2019

Event Type  malfunction  

Event Description

Cannula flip top converter became disconnected from the cap and was unintentionally pushed into patient's abdominal cavity.Was discovered in abdomen prior to end of surgery and was able to be removed from patient.

• Brand Name: VERSASTEP PLUS DILATOR AND CANNULA WITH RADIALLY EXPANDABLE SLEEVE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 9207389
• MDR Text Key: 162810751
• Report Number: 9207389
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VS101015P
• Device Catalogue Number: VS101015P
• Device Lot Number: J9A0678Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5840 DA