MAUDE Adverse Event Report: HOLOGIC, MARLBORUGH MA MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Catalog Number 10-401

Device Problem Metal Shedding Debris (1804)

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

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

Event problem and evaluation-the disposable product was returned.Gross visual analysis performed and revealed a chip on the blade assembly edge, but no fragmentation of blade edge was noted.The cutting window rim was clean indicating no bade exit occurred during procedure.No blade assembly fragments were found in return packaging.The cause of blade chip is unknown.All myosure disposables are tested for proper mechanical function and blade damage prior to qa release.This observation will be monitored and trended.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Currently unable to establish a relationship or impact to the reported observation.(b)(4).

Event Description

It was reported during a myosure procedure for uterine tissue removal on (b)(6) 2016, the physician noticed metal shavings in the patient and removed it with graspers.No patient injury and the patient was discharged home.

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, MARLBORUGH MA; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 6260632
• MDR Text Key: 65576505
• Report Number: 1222780-2017-00005
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2016

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: Physician
• Device Expiration Date: 05/30/2019
• Device Catalogue Number: 10-401
• Device Lot Number: 16E30R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2016
• 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 CONTROL UNIT-SERIAL # UNK; MYOSURE HYSTEROSCOPE-SERIAL # UNK