MAUDE Adverse Event Report: COOPERSURGICAL, INC ADVINCULA DELINEATOR UTERINE MANIPULATOR WITH 3.0 CM ULTEM KOH-EFFICIENT; CULDOSCOPE (AND ACCESSORIES)

Model Number AD750-KE30

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/10/2021

Event Type  malfunction  

Event Description

The blue cuff ring chipped while in patient, upon examination multiple damaged areas noted.Manufacturer response for uterine manipulator, (advincula delineator uterine manipulator) (per site reporter).The manufacturer provided an rma and shipping label to return the product for examination.

• Brand Name: ADVINCULA DELINEATOR UTERINE MANIPULATOR WITH 3.0 CM ULTEM KOH-EFFICIENT
• Type of Device: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL, INC; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 13059265
• MDR Text Key: 282613801
• Report Number: 13059265
• 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: 12/17/2021,12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AD750-KE30
• Device Lot Number: 299070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 102 KG