MAUDE Adverse Event Report: COOPERSURGICAL, INC. ADVINCULA DELINEATOR UTERINE MANIPULATOR; CULDOSCOPE (AND ACCESSORIES)

Model Number AD750SC-KE30

Device Problems Increase in Pressure (1491); Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 12/13/2022

Event Type  malfunction  

Event Description

Failed advincula delineator uterine manipulator.The bulb on the end of the manipulator burst when it was being inflated by the surgeon during a total laparoscopic hysterectomy with bilateral salpingectomy.

• Brand Name: ADVINCULA DELINEATOR UTERINE MANIPULATOR
• Type of Device: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate dr.; trumbull CT 06611
• MDR Report Key: 16013488
• MDR Text Key: 305795807
• Report Number: 16013488
• Device Sequence Number: 1
• Product Code: HEW
• 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: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AD750SC-KE30
• Device Lot Number: 319170
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13505 DA
• Patient Sex: Female
• Patient Weight: 94 KG