MAUDE Adverse Event Report: COOPERSURGICAL, INC. RING MANIPULATOR ARCH KOH-EFFICIENT 3.0 CM; CULDOSCOPE (AND ACCESSORIES)

Model Number KC-ARCH-30

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2021

Event Type  malfunction  

Event Description

Koh ring came off of the device during the procedure.This is something that should not happen.This is our second time this has happened.Fda safety report id # (b)(4).

• Brand Name: RING MANIPULATOR ARCH KOH-EFFICIENT 3.0 CM
• Type of Device: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL, INC.
• MDR Report Key: 12633800
• MDR Text Key: 276846833
• Report Number: MW5104616
• Device Sequence Number: 1
• Product Code: HEW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/11/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2024
• Device Model Number: KC-ARCH-30
• Device Lot Number: 301193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 83