MAUDE Adverse Event Report: HOLOGIC MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

Catalog Number 10-401HL

Device Problem Difficult To Position (1467)

Patient Problems Hematoma (1884); Tissue Damage (2104)

Event Date 11/05/2014

Event Type  Injury  

Event Description

It was reported that physician performed a myosure procedure for uterine tissue on (b)(6) 2014.Approximately 14 seconds into the procedure, the physician decided to abort due to "minimal access to (the patient's) cavity".The physician then performed a blind dilatation and curettage (d&c) and noticed "fatty tissue in her specimens sample".A laparoscopy was performed and revealed a "retro-peritoneal hematoma on the patient's left lower quadrant".The patient was admitted into the hospital overnight for observation.It is unknown if intervention was required.We have been unable to obtain additional information surrounding this event.

Manufacturer Narrative

Serial number of the myosure control unit and hysteroscope not provided by the complainant.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.If additional relevant information is received, a supplemental medwatch will be filed.Device history record (dhr) review was conducted for the reported lot number.The lot was released meeting all qa specifications.Currently unable to establish a relationship or impact to the reported observation.(b)(4).

• Brand Name: MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 4722425
• MDR Text Key: 5738831
• Report Number: 1222780-2014-00214
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122498
• 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: 11/06/2014

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 Expiration Date: 06/10/2017
• Device Catalogue Number: 10-401HL
• Device Lot Number: 14F10RA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2014
• Initial Date FDA Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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 SYSTEM; MYOSURE HYSTEROSCOPE SERIAL# UNK; CONTROL UNIT, SN UNK
• Patient Outcome(s): Hospitalization