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

Catalog Number 50-401XL

Device Problem Insufficient Information (3190)

Patient Problems Respiratory Distress (2045); Hypovolemia (2243)

Event Date 05/13/2016

Event Type  Injury  

Manufacturer Narrative

Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known.Serial number of the myosure control unit, hysteroscope and aquilex not provided by the complainant.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 not able to be conducted for the myosure system as the lot number was not provided by the complainant.If additional relevant information is received, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported during a myosure procedure for uterine tissue removal on (b)(6) 2016, the ending fluid deficit was 2300ml using saline."the patient then started to show distress and was found to have fluid in her lungs".The physician performed some testing which revealed "her levels were ok".The physician administered lasix and transferred her to a local hospital.No additional information available at this time.We have been unable to obtain additional information surrounding this event.

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016 it was reported the patient was discharged the following day and the physician said "she was just fine".

• Brand Name: MYOSURE XL 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: 5706561
• MDR Text Key: 46831770
• Report Number: 1222780-2016-00143
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122498
• 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,Followup
• Report Date: 05/13/2016

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: 50-401XL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2016
• Initial Date FDA Received: 06/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/22/2016
• 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
• Patient Outcome(s): Required Intervention