MAUDE Adverse Event Report: CONMED CORPORATION VCARE MEDIUM RETRACTOR ELEVATOR; AHLUWALIA'S RETRACTOR-ELEVATOR

Model Number 60-6085-201

Device Problem Inflation Problem (1310)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2017

Event Type  malfunction  

Event Description

Conmed vcare vaginal-cervical ahluwalia's retractor-elevator balloon would not inflate.Diagnosis or reason for use: robotic laparoscopic total hysterectomy.Is the product compounded: no.Is the product over-the-counter: no.Event abated after use stopped or dose reduced: no.

• Brand Name: VCARE MEDIUM RETRACTOR ELEVATOR
• Type of Device: AHLUWALIA'S RETRACTOR-ELEVATOR
• Manufacturer (Section D): CONMED CORPORATION; utica NY 13502
• MDR Report Key: 6412658
• MDR Text Key: 70329964
• Report Number: MW5068517
• Device Sequence Number: 1
• Product Code: LKF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2018
• Device Model Number: 60-6085-201
• Device Catalogue Number: 60-6085-201
• Device Lot Number: 201608081
• Was Device Available for Evaluation?: Yes
• 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