MAUDE Adverse Event Report: HOLOGIC MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL DEVICE

Catalog Number 10-401

Device Problem Device Handling Problem (3265)

Patient Problem Uterine Perforation (2121)

Event Date 04/01/2014

Event Type  Injury  

Event Description

It was reported that during a myosure procedure for uterine tissue removal, the physician was able to remove approx 60% of the pathology using the disposable device when the fluid deficit reached 1000ml.The physician used graspers to remove the remaining pathology.The physician then performed a hysteroscopy and "observed tissue golden in color" and suspected a perforation.It is unk if medical intervention was required.On (b)(6) 2014, it was reported that the pathology report revealed some bowel tissue.The pt's bowel was slightly pierced.The pt was admitted into the hospital for two nights for observation.It is unk if intervention was required.The physician reported "the pt is doing very 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, hysteroscope and aquilex system 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.(b)(4).

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL DEVICE
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 3800263
• MDR Text Key: 4528242
• Report Number: 1222780-2014-00069
• 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: 04/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• 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: 04/01/2014
• Date Manufacturer Received: 04/01/2014
• 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: AQUILEX FLUID SYSTEM - SERIAL # UNK; MYOSURE HYSTEROSCOPE - SERIAL# UNK; MYOSURE CONTROL UNIT - SERIAL# UNK
• Patient Outcome(s): Other