MAUDE Adverse Event Report: HOLOGIC, INC MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; UTERINE TISSUE REMOVAL SYSTEM

Catalog Number 50-501XL

Device Problem Metal Shedding Debris (1804)

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

Event Date 05/12/2017

Event Type  malfunction  

Manufacturer Narrative

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.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.Reference internal complaint (b)(4).

Event Description

It was reported the physician performed a myosure procedure for uterine tissue removal on (b)(6) 2017 and the physician noticed metal shavings in the patient's cavity.It is unknown if the metal shavings were removed.There was no patient injury.

• Brand Name: MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 6630824
• MDR Text Key: 77329963
• Report Number: 1222780-2017-00142
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/12/2017

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: 01/26/2020
• Device Catalogue Number: 50-501XL
• Device Lot Number: 17A26RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2017
• Initial Date FDA Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• 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