MAUDE Adverse Event Report: HOLOGIC INC, MYOSURE LITE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Catalog Number 30-401

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Tissue Damage (2104)

Event Date 11/10/2016

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 lot number was not provided by the complainant.(b)(4).

Event Description

It was reported during a myosure procedure for uterine tissue removal on (b)(6) 2016, the physician had difficulty with visualization and could not see what he was cutting."the patient's cervix was ripped and she was bleeding heavily".The physician "believes he perforated the uterus and may have been cutting into bowel tissue".The physician performed a hysteroscopy and "no perforation was noted".No intervention was required.

• Brand Name: MYOSURE LITE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC INC,; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 6159077
• MDR Text Key: 61911157
• Report Number: 1222780-2016-00292
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121868
• 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: 11/10/2016

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: 30-401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 12/09/2016
• 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: AQUILEX FLUID MANAGMENT SYSTEM-SN# UNK; MYOSURE CONTROL UNIT-SN# UNK; MYOSURE HYSTEROSCOPE-SN# UNK