MAUDE Adverse Event Report: COOPERSURGICAL, INC. RUMI II KOH-EFFICIENT - UTERINE MANIPULATOR; RUMI II KOH-EFFICIENT - UTERINE MANIPULATOR,

Model Number KCP-35-2

Device Problem Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Medwatch ufi report# (b)(4).(b)(6) 2016 - pt taken to or for laparoscopic vaginal hysterectomy.Rumi system uterine manipulator used.Procedure converted to open, abdominal hysterectomy.(b)(6) 2017 - pt returned to or for removal of retained koh cup that had been inserted during (b)(6) 2016 procedure.Pathology description-blue device consisting of 2 rings (4.2 cm and 2.5 cm) connected by three poles.The specimen measures 3.4 cm in height.Inscription - "coopersurgical", kcp-35, 3.5 cm.

• Brand Name: RUMI II KOH-EFFICIENT - UTERINE MANIPULATOR
• Type of Device: RUMI II KOH-EFFICIENT - UTERINE MANIPULATOR,
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC,; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6882462
• MDR Text Key: 222696114
• Report Number: 1216677-2017-00056
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KCP-35-2
• Device Catalogue Number: KCP-35-2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other