MAUDE Adverse Event Report: HASSON BALLOON; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Device Problem Material Rupture (1546)

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

Event Date 01/12/2023

Event Type  malfunction  

Event Description

Hasson balloon popped during the surgery.It was discovered right away by the surg tech.Attending surgeon and surgical team made aware.Laparoscopic examination of the abdomen performed to make sure no injury to patient occurred.Attending physician verified no injury to patient.

• Brand Name: HASSON BALLOON
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• MDR Report Key: 16466812
• MDR Text Key: 310517374
• Report Number: 16466812
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2023

1 Device was Involved in the Event

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1