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

Model Number 6001

Device Problem 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 laparoscopic 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.What was the original intended procedure? the intended procedure was a laparoscopic ovarian cystectomy.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working).

Manufacturer Narrative

(b)(4).Coopersurgical inc.Is currently investigating the reported complaint condition.A final report will be filed after customer follow up and the investigation is complete.

• Brand Name: HUMI
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOPERSURGICAL INC.; trumbull CT
• Manufacturer Contact: nana banafo ; 75 corporate dr.; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 4296344
• MDR Text Key: 5270672
• Report Number: 1216677-2014-00015
• 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: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/01/2014,09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6001
• Device Catalogue Number: 6001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 60