MAUDE Adverse Event Report: HOLOGIC MYOSURE HYSTEREOSCOPIC TISSUE REMOVAL SYSTEM; TISSUE REMOVAL DISPOSABLE DEVICE

Catalog Number 10-401

Device Problem Device Handling Problem (3265)

Patient Problem Uterine Perforation (2121)

Event Date 03/24/2014

Event Type  Injury  

Event Description

It was reported that during a myosure procedure for uterine tissue removal, the physician noted the fluid deficit was climbing to 1800 ml using saline.The physician visualized a uterine perforation and aborted the procedure.No intervention was required.

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 mfr 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 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 HYSTEREOSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: TISSUE REMOVAL DISPOSABLE DEVICE
• Manufacturer (Section D): HOLOGIC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): CYTYC CORP.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: craig callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 3779468
• MDR Text Key: 4444452
• Report Number: 1222780-2014-00066
• 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: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• 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: 03/24/2014
• Date Manufacturer Received: 03/24/2014
• 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 NUMBER UNK; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; SERIAL NUMBER UNK; CONTROL UNIT
• Patient Outcome(s): Other