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

Catalog Number 10-401FC

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Date 05/24/2017

Event Type  Injury  

Manufacturer Narrative

Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.The 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 unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.Reference internal complaint (b)(4).

Event Description

It was reported during a myosure procedure for uterine tissue removal on (b)(6) 2017, the physician "cut into the cervix where she then caused a 1 ½ inch vaginal tear".The physician then stitched the tear.The procedure was completed and the patient is "doing fine".

• Brand Name: MYOSURE REACH 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: 6656181
• MDR Text Key: 78019977
• Report Number: 1222780-2017-00156
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152723
• 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: 05/24/2017

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: 10-401FC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 06/21/2017
• 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# UNKNOWN; MYOSURE HYSTEROSCOPE:SN# UNKNOWN
• Patient Outcome(s): Required Intervention