MAUDE Adverse Event Report: COOPER SURGICAL, INC. HUMI; CANNULA, MANIPULATOR, INJECTOR

Catalog Number 6001

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 07/14/2010

Event Type  No Answer Provided  

Event Description

The patient underwent a laparoscopic supracervical hysterectomy approximately four years ago.The patient was complaining of pain in her back and pelvis.Last year a ct-scan revealed a 4.5 mm plastic tube in her pelvis.Recently, the patient underwent a diagnostic laparoscopy during which the 4.5 mm piece of plastic tubing was removed.This was identified as the tip of the harris-dronner uterine manipulator-injector (humi) uterine manipulator that was inserted into the uterus during the supracervical hysterectomy.

• Brand Name: HUMI
• Type of Device: CANNULA, MANIPULATOR, INJECTOR
• Manufacturer (Section D): COOPER SURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 3893500
• MDR Text Key: 18303729
• Report Number: 3893500
• 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: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Physician
• Device Catalogue Number: 6001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; YES, A LAP LOOP ELECTRODE WAS BEING USED.
• Patient Age: 38 YR
• Patient Weight: 51