MAUDE Adverse Event Report: COOPERSURGICAL, INC. HUMI; INSTRUMENT, MANUAL, OBSTETRIC

Model Number 6001

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/09/2017

Event Type  malfunction  

Event Description

Humi uterine manipulator was placed in vagina by physician.The physician then went to the abdomen to start the incision for laparoscopic port placement.Once ports were in place and the camera inserted into the abdomen via the ports, physician reached down to the vagina to use the manipulator.The uterus did not move around when he lifted up, but instead the plastic piece connected to the balloon snapped off.

• Brand Name: HUMI
• Type of Device: INSTRUMENT, MANUAL, OBSTETRIC
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 6823245
• MDR Text Key: 83849972
• Report Number: 6823245
• Device Sequence Number: 1
• Product Code: KNA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/20/2019
• Device Model Number: 6001
• Device Lot Number: 189118
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 79