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

Catalog Number 10-401XL

Device Problems Metal Shedding Debris (1804); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2015

Event Type  malfunction  

Event Description

It was reported that during a myosure procedure for uterine tissue removal procedure on (b)(6) 2015, the physician reported the disposable device "was leaving metal shavings in the uterus".The physician was "not concerned and did nothing to remove the foreign material", the procedure was completed "successfully" and the patient was discharged home.

Manufacturer Narrative

Concomitant product/(s): 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.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 callaahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 4751575
• MDR Text Key: 5826562
• Report Number: 1222780-2015-00074
• 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: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2017
• Device Catalogue Number: 10-401XL
• Device Lot Number: 14J16RC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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 - SERIAL# UNK; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; CONTROL UNIT - SERIAL# UNK