MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE ROD LENS HYSTEROSCOPE

Catalog Number 40-250

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Perforation (2001)

Event Type  Injury  

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).

Event Description

It was reported a physician attempted to perform a myosure procedure for uterine tissue removal.Upon entry of the scope the physician perforated the patient.The procedure was aborted.The physician "sewed up the patient" and she was discharged home.

• Brand Name: MYOSURE ROD LENS HYSTEROSCOPE
• Type of Device: HYSTEROSCOPE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: craig challahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 5403650
• MDR Text Key: 37335805
• Report Number: 1222780-2016-00021
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/31/2015

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: 40-250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2016
• 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
• Patient Outcome(s): Required Intervention