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

Catalog Number 10-401

Device Problem Insufficient Information (3190)

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994); Septic Shock (2068); Peritonitis (2252)

Event Date 06/21/2017

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 and sterile lot review were unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.If additional relevant information is received, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported the physician completed myosure procedure for uterine tissue removal on (b)(6) 2017 and the patient was discharged home.The evening post procedure the patient presented to the emergency room (er) and was admitted into the intensive care unit (icu).The patient reported after "having a bite to eat she had horrific pain".The physician confirmed the patient was "hypertensive and septic" and performed an "exploratory laparoscopy, sigmoidoscopy, colostomy and uterine repair".The exploratory procedures revealed bowel movement in the patient's abdomen.The physician diagnosed the patient with "iatrogenic uterine sigmoid caused by medical procedure with peritonitis".The patient had some lung complications and was still in the hospital.We have been unable to obtain additional information surrounding this event.

• Brand Name: MYOSURE 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: 6750309
• MDR Text Key: 81275537
• Report Number: 1222780-2017-00194
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 10-401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2017
• 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: SERIAL NUMBER UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention