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

Catalog Number 50-401XL

Device Problem Device Handling Problem (3265)

Patient Problem Uterine Perforation (2121)

Event Date 03/17/2014

Event Type  Injury  

Event Description

It was reported that during a myosure procedure for uterine tissue removal, the fluid deficit "quickly reached 300ml" and "the pt was experiencing bradycardia and showing signs of edema".The physician suspected a uterine perforation and cauterized "to seal the {suspected} perforation".There was no injury to the bowel noted.No other intervention was required.The moysure procedure was aborted and the pt went to the recovery room.The pt recovered well; heart rate returned to normal and was awake in the recovery room.

Manufacturer Narrative

Serial number of the myosure control unit and hysteroscope not provided by the complainant.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: TISSUE REMOVAL DEVICE
• Manufacturer (Section D): HOLOGIC; marlborough MA
• Manufacturer Contact: craig callahan, sr mgr ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 3767502
• MDR Text Key: 4486549
• Report Number: 1222780-2014-00059
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K122498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2016
• Device Catalogue Number: 50-401XL
• Device Lot Number: 13F07R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/17/2014
• Device Age: 9 MO
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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: SERIAL # UNK; MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYS CONTROL,; UNIT SERIAL # UNK. MYOSURE HYSTEROSCOPE,
• Patient Outcome(s): Required Intervention