MAUDE Adverse Event Report: HOLOGIC MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

Catalog Number 10-401

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

Patient Problem Bleeding (1738)

Event Date 02/21/2014

Event Type  Injury  

Event Description

It was reported that during a myosure procedure for uterine tissue removal on (b)(6) 2014, the physician "injected vasopressin to help with the bleeding the patient was experiencing." after the procedure was completed "the doctor inserted a foley catheter to help stop the bleeding." on (b)(6) 2014, it was reported that the amount of bleeding is unk.The physician first used a 10cc foley catheter and then went to a 30cc foley catheter.The patient was admitted on (b)(6) 2014.The foley catheter was removed the following day with no complications.The patient was discharge on (b)(6) 2014.

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 and hysteroscope 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 complainant.(b)(4).

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan, manager ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 3716121
• MDR Text Key: 4249000
• Report Number: 1222780-2014-00041
• 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: 02/21/2014

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/21/2014
• Initial Date Manufacturer Received: 02/14/2014
• Initial Date FDA Received: 03/22/2014
• 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: Initial
• Patient Sequence Number: 1
• Treatment: MYOSURE HYSTEROSCOPE: SN UNK; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; CONTROL UNIT: SN UNK
• Patient Outcome(s): Hospitalization; Required Intervention