MAUDE Adverse Event Report: HOLOGIC MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

Catalog Number 10-401

Device Problem Device Handling Problem (3265)

Patient Problem Pain (1994)

Event Date 01/23/2014

Event Type  Injury  

Event Description

It was reported that during a myosure procedure for uterine tissue removal on (b)(6) 2014, the physician "resected approximately 90 percent (of the polyp) with a myosure classic device.She then completed the resection with blind curetting".The fluid deficit was noted to be 2000cc.The physician then performed a hysteroscopy and the polyp was removed successfully.The patient was discharged home.The patient returned to the emergency room later that evening complaining of shoulder pain."the e.R.Did testing and found she had a perforation in her uterus in the same location of where the pathology was removed.They did a laparoscopy and closed up the perforation.They found 700cc of blood in her abdomen.She received 1 unit of blood.She stayed overnight and was released saturday (b)(6) 2014".

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).

• 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: 3750750
• MDR Text Key: 4464772
• Report Number: 1222780-2014-00029
• 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: 01/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2014
• 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: 01/23/2014
• Date Manufacturer Received: 01/26/2014
• 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 HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; SALINE DISTENTION MEDIA; CONTROL UNIT - SERIAL NUMBER UNK; MYOSURE HYSTEROSCOPE - SERIAL NUMBER UNK
• Patient Outcome(s): Hospitalization; Required Intervention