MAUDE Adverse Event Report: HOLOGIC MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

Catalog Number 10-401

Device Problem Device Handling Problem (3265)

Patient Problem Uterine Perforation (2121)

Event Date 12/17/2013

Event Type  Injury  

Event Description

It was reported that during a myosure procedure for uterine tissue removal on (b)(4) 2013, the fluid deficit was rising quickly.The physician suspected there was a perforation.The physician "cut a few more minutes and then aborted the procedure".A laparoscopy was performed and confirmed a "large perforation".The physician sutured the perforation site.It was reported on (b)(6) 2014, that the pt was discharged home after the attempted myosure procedure "without an issue" and the pt is currently doing well.

Manufacturer Narrative

Lot number of the disposable device not provided by the complainant, therefore, the expiration date is not known.Serial number of the myosure control unit and hysteroscope not provided by the complainant.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.Myosure hysteroscope.According to the instructions for use (ifu) warning: uterine perforation can result in possible injury to bowel, bladder, major blood vessels, and ureter.Myosure disposable.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).

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan, mgr ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 3600509
• MDR Text Key: 4069966
• Report Number: 1222780-2014-00011
• 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: 12/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10-401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/17/2013
• Date Manufacturer Received: 12/17/2013
• 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: SALINE DISTENTION MEDIA; MYOSURE HYSTEROSCOPE - SERIAL NUMBER UNK; CONTROL UNIT - SERIAL NUMBER UNK; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Patient Outcome(s): Required Intervention