MAUDE Adverse Event Report: HOLOGIC, MARLBORUGH MA MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Catalog Number 10-401

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Abdominal Distention (2601)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

The disposable device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was not able to be conducted for the myosure system as the identification numbers were not provided by the complainant.(b)(4).

Event Description

It was reported during a myosure procedure for uterine tissue removal the patient's "fluid deficit spiked from 1000cc-4100cc.The procedure was aborted.The patient was then rushed to intensive care unit (icu) with distended abdomen." a laparoscopy was performed and the physician noted "blood in the abdomen." the patient was admitted into the hospital overnight and discharged the following day.It is unknown if intervention was required.We have been unable to obtain additional information surrounding this event.

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, MARLBORUGH MA; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 5489355
• MDR Text Key: 39982983
• Report Number: 1222780-2016-00053
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 10-401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2016
• Initial Date FDA Received: 03/09/2016
• 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
• Treatment: MYOSURE HYSTEROSCOPE-SERIAL # UNK
• Patient Outcome(s): Hospitalization