MAUDE Adverse Event Report: CYTYC CORP. MYOSURE ROD LENS HYSTEROSCOPE; UTERINE HYSTEROSCOPE

Catalog Number 40-250

Device Problem Device Handling Problem (3265)

Patient Problem Uterine Perforation (2121)

Event Date 03/24/2014

Event Type  Injury  

Event Description

It was reported that prior to a myosure procedure for uterine tissue removal, the physician dilated the pt and inserted the myosure hysteroscope.The fluid deficit reached "154ml" and at this point, the physician ordered an ultrasound.A uterine perforation was visualized on ultrasound and laparoscopy.It is unk if intervention was required.We have been unable to obtain add'l info surrounding this event.

Manufacturer Narrative

The myosure hysteroscope is not being returned therefore, a failure analysis of the myosure hysteroscope cannot be completed.Device history record (dhr) review was not able to be conducted for the myosure hysteroscope as product identification numbers were not provided by the complainant.According to the instructions for use (ifu) warnings: uterine perforation can result in possible injury to bowel, bladder, major blood vessels, and ureter.Precautions: to avoid perforation, do not use the scope tip as a probe and exercise caution when the scope is being inserted through the cervix and when the scope tip is near the uterine wall.(b)(4).

• Brand Name: MYOSURE ROD LENS HYSTEROSCOPE
• Type of Device: UTERINE HYSTEROSCOPE
• Manufacturer (Section D): CYTYC CORP.; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: craig callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 3779453
• MDR Text Key: 4444456
• Report Number: 1222780-2014-00065
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091465
• 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: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 40-250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/24/2014
• Date Manufacturer Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SYSTEM CONTROL UNIT; SERIAL NUMBER UNK; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL
• Patient Outcome(s): Other