MAUDE Adverse Event Report: HOLOGIC MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

Catalog Number 10-401

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Code Available (3191)

Event Date 05/21/2015

Event Type  Injury  

Event Description

It was reported that during a myosure procedure for uterine tissues removal on (b)(6) 2015, the patient's fluid deficit started to rise quickly and reached 2100cc.At this point, the physician suspected a perforation and aborted the procedure.There was no intervention required and the patient was discharged.

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.Reference internal complaint (b)(4).

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 4863015
• MDR Text Key: 5867458
• Report Number: 1222780-2015-00110
• 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: 05/21/2015

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: 05/21/2015
• Initial Date FDA Received: 06/19/2015
• 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 HYSTEROSCOPIC TISSUE REMOVAL SYS. CONTROL; MYOSURE HYSTEROSCOPE- SERIAL # UNK
• Patient Outcome(s): Other