MAUDE Adverse Event Report: COVIDIEN LLC. ACCESS PORT 12MM SPACEMAKER PRO; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number SMBTTOVLX

Device Problem Burst Container or Vessel (1074)

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

Event Date 07/10/2019

Event Type  malfunction  

Event Description

Balloon burst while in use and in the pt.No pieces tore off balloon.Surgeon did not feel it punctured or anything sharp.

• Brand Name: ACCESS PORT 12MM SPACEMAKER PRO
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LLC. ; mansfield MA
• MDR Report Key: 9203028
• MDR Text Key: 162885613
• Report Number: MW5090447
• 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: No Information
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMBTTOVLX
• Device Catalogue Number: SMBTTOVLX
• Was Device Available for Evaluation?: Yes
• 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 Age: 62 YR