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

Catalog Number 10-401

Device Problem Insufficient Information (3190)

Patient Problems Perforation (2001); Complaint, Ill-Defined (2331)

Event Date 05/15/2015

Event Type  Injury  

Event Description

It was reported that during a myosure procedure for uterine tissue removal on (b)(6)2015 the fluid deficit started to climb.At this point, the physician checked the pt's uterine cavity and found "one perforation area near the left side of the fundus".The procedure was aborted.It was unk if intervention was required.We have been unable to obtain add'l info surrounding this event.

Manufacturer Narrative

Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known.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 mfg date is not known.If add'l relevant info is rec'd, a supplemental medwatch will be filed.Device history record (dhr) review was not able to be conducted for the myosure sys 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).

• 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: 4853544
• MDR Text Key: 20778156
• Report Number: 1222780-2015-00106
• 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: 05/15/2015

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: Health Professional
• Device Catalogue Number: 10-401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 06/15/2015
• 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: CONTROL UNIT- SERIAL# UNK.; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM,; MYOSURE HYSTEROSCOPE-SERIAL# UNK
• Patient Outcome(s): Other