MAUDE Adverse Event Report: HOLOGIC, MARLBORUGH MA MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Catalog Number 10-401

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Currently unable to establish a relationship or impact to the reported observation.If additional relevant information is received, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported the physician performed a myosure procedure for uterine tissue removal on (b)(6) 2017, and during the procedure the tip of the device broke off inside the patient's uterus.The physician suctioned out the tip and an x-ray was performed to confirm no other fragments were left inside the patient.No patient injury.The procedure was completed and the patient was discharged home.

Manufacturer Narrative

(b)(4).

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, MARLBORUGH MA; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 6397170
• MDR Text Key: 69995367
• Report Number: 1222780-2017-00060
• 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 faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 10-401
• Device Lot Number: 16G19RB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2016
• 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-SERIAL # UNK; MYOSURE HYSTEROSCOPE-SERIAL # UNK