MAUDE Adverse Event Report: COOPER SURGICAL, INC. ARCH KOH-EFFICIENT ¿ 3.5 CM UTERINE MANIPULATOR; CULDOSCOPE (AND ACCESSORIES)

Model Number KC-ARCH-35

Patient Problem Foreign Body In Patient (2687)

Event Date 07/27/2023

Event Type  malfunction  

Event Description

The blue plastic cup "koh cup" from arch koh-efficient ¿ 3.5 cm was separated and retained in the patient after the surgical procedure.It was revealed in the follow up visit and was removed.

• Brand Name: ARCH KOH-EFFICIENT ¿ 3.5 CM UTERINE MANIPULATOR
• Type of Device: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COOPER SURGICAL, INC.
• MDR Report Key: 17836604
• MDR Text Key: 324661619
• Report Number: MW5146265
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2024
• Device Model Number: KC-ARCH-35
• Device Catalogue Number: KC-ARCH-35
• Device Lot Number: 299095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 72 KG