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

Catalog Number 10-401XL

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/17/2014

Event Type  Injury  

Event Description

It was reported that a physician performed a myosure for uterine tissue removal procedure on (b)(6) 2014.The first disposable device was not functioning properly.The physician used a second device and it worked well.The pt had a fluid deficit of 2ml and the physician administered lasix.There was no "pt injury".

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 eval completed, a supplemental medwatch will be filed.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
• Type of Device: UTERINE TISSUE REMOVAL DEVICE
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 4372854
• MDR Text Key: 5286347
• Report Number: 1222780-2014-00224
• 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: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2017
• Device Catalogue Number: 10-401XL
• Device Lot Number: 14G22RA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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; HYSTEROSCOPE NOT PROVIDED BY THE COMPLAINANT; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM; SERIAL NUMBER OF THE MYOSURE CONTROL UNIT AND; CONTROL UNIT- SERIAL UNK
• Patient Outcome(s): Required Intervention