MAUDE Adverse Event Report: CONMED CORPORATION VCARE MEDIUM, VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR ELEVATOR UTERINE MANIPULATO; CANNULA, MANIPULATOR / INJECTOR , UTERINE

Model Number 60-6085-201A

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 03/22/2019

Event Type  malfunction  

Event Description

While attempting to utilize the conmed corporation vcare medium vaginal-cervical-ahluwalia's-retractor elevator uterine manipulator according to mfr's recommendations, the blue portions of the catheter would not approximate, thereby not tightening, and not allowing the catheter to be utilized.

• Brand Name: VCARE MEDIUM, VAGINAL-CERVICAL-AHLUWALIA'S-RETRACTOR ELEVATOR UTERINE MANIPULATO
• Type of Device: CANNULA, MANIPULATOR / INJECTOR , UTERINE
• Manufacturer (Section D): CONMED CORPORATION; utica NY 13502
• MDR Report Key: 8456151
• MDR Text Key: 140283691
• Report Number: MW5085187
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• 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: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2021
• Device Model Number: 60-6085-201A
• Device Catalogue Number: 60-6085-201A
• Device Lot Number: 201901281
• 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
• Patient Age: 52 YR