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

Model Number KC-RUMI-30

Device Problems Inflation Problem (1310); Difficult To Position (1467)

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

Event Date 08/29/2017

Event Type  malfunction  

Event Description

Surgeon was placing intrauterine tip in preparation for laparoscopic hysterectomy.Surgeon attempted to fill balloon for appropriate placement but balloon failed after filling less then 30ml saline and would not inflate.Placement of manipulator failed and a new tip was used.

• Brand Name: RUMI II
• Type of Device: CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 6837481
• MDR Text Key: 84326932
• Report Number: 6837481
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: KC-RUMI-30
• Device Catalogue Number: KC-RUMI-30
• Device Lot Number: 204941
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2017
• 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
• Treatment: NONE RELATED TO THIS DEVICE
• Patient Age: 44 YR
• Patient Weight: 106