MAUDE Adverse Event Report: HOLOGIC, MARLBORUGH MA MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Catalog Number 10-401

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2015

Event Type  Injury  

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.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).

Event Description

It was reported the physician performed a myosure procedure for uterine tissue removal on (b)(6) 2015.During the procedure "the fluid deficit began to increase rapidly." the physician then used a hysteroscope and the fluid deficit still continued to rise and was noted 750ml.The physician suspected a perforation and aborted the procedure.No intervention was required.

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, MARLBORUGH MA; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 5354337
• MDR Text Key: 35454442
• Report Number: 1222780-2016-00007
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2015

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2016
• 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
• Patient Outcome(s): Other