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

Model Number 10-401FC

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

Patient Problems Bradycardia (1751); Uterine Perforation (2121)

Event Date 04/08/2019

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 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 unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.Internal complaint reference: (b)(4).

Event Description

It was reported that during a myosure tissue removal procedure a small polyp was removed.The physician removed the scope to curette the patient and when the scope was reinserted the fluid deficit began to increase from 190 to 400ml and the physician noted a "hole." the patients heart rate decreased and an unknown medication was given by anesthesia to correct the bradycardia.The patient was awake and doing fine and was observed in the recovery room before being discharged home.The patient is currently doing well with no further issues.

• Brand Name: MYOSURE REACH HYSTEROSCOPIC TISSUE REMOVAL DEVICE
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 8549311
• MDR Text Key: 143059912
• Report Number: 1222780-2019-00099
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152723
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10-401FC
• Device Catalogue Number: 10-401FC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2019
• 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; Other; Required Intervention