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

Model Number AD750SC-KE40

Device Problems Thermal Decomposition of Device (1071); Flaked (1246); Melted (1385); Overheating of Device (1437)

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

Event Date 05/04/2020

Event Type  malfunction  

Event Description

While performing a robotic laparoscopic hysterectomy it became apparent that the co-ring on the copper uterine manipulator was melting and chips were flaking into the patient during the colpotomy portion of the case.The ring was being burned despite coagulation settings being at 35.

• 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: 10046543
• MDR Text Key: 190623354
• Report Number: 10046543
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AD750SC-KE40
• Device Lot Number: 280716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15330 DA