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

Catalog Number 10-401

Device Problem Insufficient Information (3190)

Patient Problem Uterine Perforation (2121)

Event Date 11/12/2014

Event Type  Injury  

Event Description

It was reported a physician performed a myosure procedure for uterine tissue removal on (b)(6) 2014.During the procedure the fluid deficit increased.The physician suspected a uterine perforation and aborted the procedure.It is unk if intervention was required.We have been unable to obtain additional info surrounding this event.

Manufacturer Narrative

Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known.Concomitant product :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 manufacture date is not known.If additional relevant info is received, a supplemental medwatch will be filed.Device history record (dhr) review was not able to be conducted for the myosure device as the lot number was not provided by the complainant.(b)(4).

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYS
• 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: 4351143
• MDR Text Key: 5138511
• Report Number: 1222780-2014-00219
• 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: 11/12/2014

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: 11/12/2014
• Initial Date FDA Received: 12/12/2014
• 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: CONTROL UNIT-SERIAL NUMBER UNK; MYOSURE HYSTEROSCOPE-SERIAL # UNK; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYS,
• Patient Outcome(s): Other