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

Model Number AD750SC-KE35

Device Problem Melted (1385)

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

Event Date 09/15/2021

Event Type  malfunction  

Event Description

Per surgical staff, the uterine manipulator device appeared to be melting during the colpotomy portion of a procedure as robotic arm was cutting/coagulating the tissue from the device.No harm came to the patient or healthcare providers and the procedure was finished as planned.

• 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: 12567748
• MDR Text Key: 274469094
• Report Number: 12567748
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AD750SC-KE35
• Device Lot Number: 300564
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2021
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16790 DA
• Patient Weight: 119