MAUDE Adverse Event Report: HOLOGIC MYOSURE HYSTEROSCOPIC TISSUE REMOAL SYSTEM; UTERINE TISSUE REMOVAL DEICE

Catalog Number 10-401

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Tachycardia (2095); Hypovolemia (2243); Low Oxygen Saturation (2477)

Event Date 10/09/2014

Event Type  Injury  

Event Description

It was reported that physician performed a myosure procedure for uterine tissue removal on (b)(6) 2014.The fluid deficit was slowly rising and the physician continued with the procedure.The fluid deficit reached "2889ml" and the pt exhibited "decreased oxygen saturations and a slightly increased heart rate".The physician did not suspect a perforation.The procedure was aborted.The physician administered lasix and intubated the pt.The pt was admitted overnight for observation and discharged the following day.On (b)(6) 2014, it was reported that "the issue was related to an air embolism during the procedure".

Manufacturer Narrative

Lot number of the disposable device not provided by the complainant, therefore, the expiration date is not known.Concomitant products: serial number of the myosure control unit, hysteroscope and aquilex not provided by the complainant.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 lot number was not provided by the complaint.(b)(4).

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL DEICE
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 4257474
• MDR Text Key: 15346770
• Report Number: 1222780-2014-00190
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2014

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: Health Professional
• Device Catalogue Number: 10-401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2014
• Initial Date FDA Received: 11/07/2014
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; CONTROL UNIT - SERIAL NUMBER UNK; MYOSURE HYSTEROSCOPE -SERIAL # UNK
• Patient Outcome(s): Hospitalization; Required Intervention