MAUDE Adverse Event Report: HOLOGIC MYOSURE ROD LENS HYSTEROSCOPE

Catalog Number 40-250

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 12/04/2014

Event Type  Injury  

Event Description

It was reported that a physician attempted to perform a myosure procedure for uterine tissue removal on (b)(6) 2014.A dilatation and curettage (d & c) with a hysteroscopy was initially done at the start of the case.The physician then switched to a myosure hysteroscope and the fluid deficit increased to 1100ml.As the physician removed the myosure hysteroscope "she perforated with the scope in the left coruna area".A laparoscopy was performed and no adjacent injury was visualized and no intervention required.The pt was discharged home.

Manufacturer Narrative

The myosure hysteroscope is not being returned therefore, a failure analysis of the myosure hysteroscope can not 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: HYSTEROSCOPE
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 4372886
• MDR Text Key: 5263761
• Report Number: 1222780-2014-00228
• 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: 12/04/2014

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: 40-250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2014
• Initial Date FDA Received: 12/23/2014
• 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: MYOSURE TRD - LOT NUMBER UNK; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; CONTROL UNIT-SERIAL UNK
• Patient Outcome(s): Other