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

Catalog Number 50-401XL DEVICES

Device Problem Metal Shedding Debris (1804)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

The disposable device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was not able to be conducted for the myosure system as the identification numbers were not provided by the complainant.(b)(4).

Event Description

It was reported that during a myosure procedure for uterine tissue removal on (b)(6) 2016, the physician viewed "a lot [of] metal shaving inside the cavity.The metal shavings were aspirated out and the procedure was completed.The "surgeon was happy with the outcome" and the "patient was discharged [home].".

• 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: 5953030
• MDR Text Key: 55205995
• Report Number: 1222780-2016-00231
• 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: 08/17/2016

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 Catalogue Number: 50-401XL DEVICES
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: No
• 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-SN# UNK; MYOSURE HYSTEROSCOPE-SN# UNK