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

Catalog Number 10-401FC

Device Problem Metal Shedding Debris (1804)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/22/2017

Event Type  malfunction  

Manufacturer Narrative

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.Device evaluation and event problem codes: the returned device was received, visually inspected, and tested.Visual examination of trd noted light scribe marks on the cutting window rim.This visual inspection indicative the blade damage was due to the user handling of the device.(b)(4).

Event Description

It was reported the physician performed a myosure procedure for uterine tissue removal on (b)(6) 2017 and the physician noted the "cutting blade shaved metal into the cavity." the physician removed the shaving from the patient.No patient injury.The procedure was completed and the patient was discharged home.

• Brand Name: MYOSURE REACH 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: 6511650
• MDR Text Key: 73734197
• Report Number: 1222780-2017-00094
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152723
• 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: 03/23/2017

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: 06/30/2019
• Device Catalogue Number: 10-401FC
• Device Lot Number: 16F20RB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2017
• Initial Date FDA Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2016
• 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
• Patient Outcome(s): Hospitalization