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

Catalog Number 10-401

Device Problems Decrease in Pressure (1490); Infusion or Flow Problem (2964)

Patient Problem Muscle Spasm(s) (1966)

Event Date 07/13/2015

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 product identification number was not provided by the complainant.Reference internal complaint : (b)(4).The device is not returning.

Event Description

It was reported during a myosure procedure for uterine tissue removal on (b)(6) 2015, the physician had difficulty with distention and pressure not holding.The physician removed the device and re-clamped the patient.The physician then reinserted the disposable device and started to cut.The fluid deficit was "1943cc".At this point, the "patient seemed to have awaken.Her legs clenched.Emergency equipment was brought into the room, patient seemed to be stabilized and she is believed to have pulmonary edema".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: callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 4988596
• MDR Text Key: 22489714
• Report Number: 1222780-2015-00143
• 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
• Report Date: 07/13/2015

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: 10-401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: No
• 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 HYSTEROSCOPE-SN# UNK
• Patient Outcome(s): Required Intervention