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

Catalog Number 10-401FC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Uterine Perforation (2121); Injury (2348)

Event Date 06/27/2017

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.According to the instructions for use (ifu) warnings: to avoid perforation, keep the device tip under direct visualization and exercise care at all times when maneuvering it or cutting it close to the uterine wall.Never use the device tip as a probe or dissecting tool.Reference internal complaint cc#(b)(4).

Event Description

It was reported the physician performed a myosure procedure for uterine tissue removal on (b)(6) 2017 and the fluid deficit started to rise.The physician aborted the procedure and performed a laparoscopy which revealed a "large perforation and a superficial wound on the wall of the uterus".The physician stitched the perforation and gel was applied to stop the bleeding.There was no bowel injury noted.The patient was admitted into the hospital overnight for observation and discharged the following day.

• 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: 6747562
• MDR Text Key: 81181257
• Report Number: 1222780-2017-00191
• 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: 06/27/2017

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/27/2017
• 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 CONTROLLER: SERIAL NUMBER UNKONWN
• Patient Outcome(s): Hospitalization; Required Intervention