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

Model Number AD750SC-KE40

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/21/2022

Event Type  malfunction  

Event Description

Balloon from advincula delineator was removed from the manipulator and left in the patient.Recommend that the balloon (pneumo occluder) not be a detachable item.

• Brand Name: ADVINCULA DELINEATOR UTERINE MANIPULATOR
• Type of Device: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 17331938
• MDR Text Key: 319113246
• Report Number: 17331938
• Device Sequence Number: 1
• Product Code: HEW
• UDI-Device Identifier: 00888937021370
• UDI-Public: (01)00888937021370(10)305275(17)240510
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AD750SC-KE40
• Device Catalogue Number: AD750SC-KE40
• Device Lot Number: 305275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7665 DA
• Patient Sex: Female