MAUDE Adverse Event Report: CONMED ENDOSURGERY VCARE; CONMED VCARE

Device Problems Detachment Of Device Component (1104); Torn Material (3024)

Patient Problems Abscess (1690); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)

Event Date 02/11/2015

Event Type  malfunction  

Event Description

Patient underwent a laparoscopic robotic hysterectomy.Discharged home and returned for a second admission.During a second surgery a 1 cm piece of soft plastic from neck of balloon on vaginal manipulator was found to be retained in the patient.Upon investigation, piece was noted to be torn from balloon.Cervical cuff had been retained and removed during original procedure.It is believed that traction against cervical cup while removing vaginal manipulator during original procedure caused tear and retained piece.It is not known conclusively that the retained piece caused harm to the patient who also had a small bowel obstruction with abscess.

• Brand Name: VCARE
• Type of Device: CONMED VCARE
• Manufacturer (Section D): CONMED ENDOSURGERY; 525 french rd.; utica NY 13502
• MDR Report Key: 4794727
• MDR Text Key: 5818202
• Report Number: 4794727
• Device Sequence Number: 1
• Product Code: LKF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR