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

Model Number AD750SC-KE35

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

Event Type  malfunction  

Event Description

Uterine manipulator's plastic handle piece separated while surgeon was performing uterine manipulation.No patient injury occurred another uterine manipulator with the same lot # was opened.This one had no defect.

• 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: 10307434
• MDR Text Key: 199864370
• Report Number: 10307434
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AD750SC-KE35
• Device Catalogue Number: AD750SC-KE35
• Device Lot Number: 285768
• 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: 07/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Weight: 58