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

Model Number 50-501XL

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

Patient Problem Air Embolism (1697)

Event Date 05/16/2019

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 has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.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 or the radio frequency controller as the identification numbers were not provided by the complainant.

Event Description

It was reported to a hologic representative by a physician that a few months ago he was performing a fibroid removal procedure and suddenly the patient oxygen saturation level dropped.The proceduralist and anesthesiologist both confirmed that there were no error messages or alarms coming from the device and that the procedure was uncomplicated until about 45 minutes in when the patient began to desaturate.Fio2 was increased to 100% and respirations were assisted by hand but her oxygenation continued to deteriorate over 5 minutes.A cardiorespiratory arrest was called and subsequently the patient was emergently intubated.Despite good air entry bilaterally, the patient oxygenation did not improve.The patient was then positioned steep head down and her saturation returned to normal within 30 seconds.Cpr was never required.The patient was diagnosed with an air embolism related to hysteroscopic insufflation.It was noted by the gynae registrar that although the procedure was uncomplicated, the field of view became blood stained right before the initial desaturation.Patient blood pressure required support.A low dose adrenaline infusion was given along with an albumex and crystalloid infusion.Patient was transferred to the icu for recovery and was extubated the following day.No additional details available.

• 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: kelsea lyver ; 250 campus drive; marlborough, MA 01752 ; 5082636130
• MDR Report Key: 9467855
• MDR Text Key: 172189553
• Report Number: 1222780-2019-00280
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50-501XL
• Device Catalogue Number: 50-501XL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2019
• 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): Hospitalization; Life Threatening; Other; Required Intervention