MAUDE Adverse Event Report: COOPERSURGICAL INC. COOPER SURGICAL ADVINCULA DEVICE; CULDOSCOPE (AND ACCESSORIES)

Model Number AD750-KE30

Device Problems Inflation Problem (1310); Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2020

Event Type  malfunction  

Event Description

Advincula device was unable to be secured by physician.Another physician also tried.This physician removed device and tried to inflate cuff/balloon- it would not inflate.Physician used a vcare instead.No issues with vcare.Fda safety report id # (b)(4).

• Brand Name: COOPER SURGICAL ADVINCULA DEVICE
• Type of Device: CULDOSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL INC.
• MDR Report Key: 11076481
• MDR Text Key: 224104340
• Report Number: MW5098540
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AD750-KE30
• Device Lot Number: 292327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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