MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE ROD LENS HYSTEROSCOPE

Catalog Number 40-250

Device Problem Insufficient Information (3190)

Patient Problems Air Embolism (1697); Low Oxygen Saturation (2477)

Event Date 05/13/2016

Event Type  Injury  

Manufacturer Narrative

The myosure hysteroscope is not being returned therefore, a failure analysis of the myosure hysteroscope can not be completed.Device history record (dhr) review was not able to be conducted for the myosure hysteroscope as product identification numbers were not provided by the complainant.(b)(4).

Event Description

It was reported a physician attempted to perform a myosure procedure for uterine tissue removal on (b)(6)2016.The physician inserted the myosure hysteroscope "before prime cycle was completed.About 30 seconds into the procedure the doctor was trying to locate the pathology and the patients oxygen levels began to drop".The physician got the "oxygen levels back into the 90s".The procedure was aborted and the patient was transferred to the intensive care unit (icu).An hour after the attempted uterine tissue removal procedure the patient was still incubated.Later on that day, the patient was transferred out of the icu and was administered lasix and underwent a chest x-ray.The doctor "diagnosed the patient with an air embolus due to the hysteroscope being inserted too soon forcing air to enter the uterine cavity".The patient was discharged home on (b)(6) 2016.

• Brand Name: MYOSURE ROD LENS HYSTEROSCOPE
• Type of Device: HYSTEROSCOPE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 5706534
• MDR Text Key: 46830325
• Report Number: 1222780-2016-00144
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091465
• 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: 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: 40-250
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: AQUILEX FLUID MANAGEMENT SYSTEM-SERIAL UNK
• Patient Outcome(s): Hospitalization; Required Intervention