MAUDE Adverse Event Report: COOPERSURGICAL, INC. HUMI; CANNULA, MANIPULATOR/INJECTOR, UTERINE

Catalog Number 6001

Device Problems Break (1069); Detachment Of Device Component (1104); Component Missing (2306)

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

Event Date 07/11/2014

Event Type  malfunction  

Event Description

The patient was undergoing a laparascopic ovarian cystectomy.About forty-five minutes into the case the surgical technician advised the surgeon that something was not right with the humi.The device was removed and it was obvious that the tip with the spring was missing.The broken piece was retrieved at the end of the case.

• Brand Name: HUMI
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate dr.; trumbull CT 06611
• MDR Report Key: 4160682
• MDR Text Key: 4772362
• Report Number: 4160682
• 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
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 6001
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2014
• Patient Sequence Number: 1
• Treatment: A LAPAROSCOPIC ENDOGRASPER, AND A HARMONIC SCALPEL; WERE ALSO USED.; NO OTHER THERAPIES
• Patient Age: 30 YR
• Patient Weight: 60