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 Perforation (2001); Fluid Discharge (2686)

Event Date 07/06/2015

Event Type  Injury  

Event Description

It was reported a physician performed a myosure procedure for uterine tissue removal on (b)(6) 2015 and "midway through the procedure the fluid deficit began to increase".The physician then stopped, performed a laparoscopy, and "noticed a perforation".The procedure was aborted.On (b)(6) 2015, it was reported the physician "cauterized the hole, and packed it with floseal/intercede".The physician suctioned the fluid out of the patient's cavity and the fluid deficit was well below 2500cc.The patient was admitted overnight for observation and discharged home the following day.

Manufacturer Narrative

Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known.The disposable device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known.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.According to the instructions for use (ifu) warnings: to avoid perforation, keep the device tip under direct visualization and exercise care at all times when maneuvering it or cutting it close to the uterine wall.Never use the device tip as a probe or dissecting tool.(b)(4).The device is not returning.

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, MARLBORUGH MA; 250 campus drive; marlborugh MA 01752
• Manufacturer Contact: callahan, pmqa manager ; 250 camputs drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 4956407
• MDR Text Key: 6036967
• Report Number: 1222780-2015-00132
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: No
• 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 NUMBER UNK; MYOSRUE CONTROL UNIT-SERIAL NUMBER UNK
• Patient Outcome(s): Hospitalization; Required Intervention