MAUDE Adverse Event Report: HOLOGIC INC, MYOSURE LITE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Catalog Number 30-401

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Perforation (2001)

Event Date 11/30/2016

Event Type  Injury  

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 manufacture date is not known.Device history record (dhr) review was not able to be conducted for the myosure system as the lot number was not provided by the complainant.(b)(4).

Event Description

It was reported during a myosure procedure for uterine tissue removal on (b)(6) 2016, the physician "pushed the device too far and caused a perforation".The procedure was aborted.The physician did not have to perform a hysterectomy.The "patient was discharged and everything was fine".

• Brand Name: MYOSURE LITE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC INC,; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 6212160
• MDR Text Key: 63477173
• Report Number: 1222780-2016-00322
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121868
• 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: 12/02/2016

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: 30-401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/29/2016
• 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: MYOSURE CONTROL UNIT-SN# UNK; MYOSURE HYSTEROSCOPE-SN# UNK
• Patient Outcome(s): Other