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

Catalog Number 30-401

Device Problem Insufficient Information (3190)

Patient Problem Abdominal Distention (2601)

Event Date 09/11/2015

Event Type  Injury  

Manufacturer Narrative

Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known.Concomitant product(s): serial number of the myosure control unit and hysteroscope not provided by the complainant.The disposable device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known.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).The device is not returning.

Event Description

It was reported a physician performed a myosure for uterine tissue removal procedure on (b)(6) 2015.It was noted that the fluid deficit was 1500cc using saline.The patient showed "signs and symptoms of flash pulmonary edema".The patient also "exhibited a distended abdomen".The patient was admitted into the hospital and "received intubation by endotracheal tube and suction of such, iv diuretics and an orogastric tube to enable suction of the abdominal contents.Upon arrival at the hospital, the patient received a chest and abdominal x-ray".Results are unknown.The patient was discharged home on (b)(6) 2015 and currently "doing fine".

• Brand Name: MYOSURE LITE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: UTERINE TISSUE REMOVAL SYSTEM
• Manufacturer (Section D): HOLOGIC INC,; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: callahan ; 250 campus drive; marlborough, MA 01752 ; 5082638859
• MDR Report Key: 5138621
• MDR Text Key: 27919694
• Report Number: 1222780-2015-00178
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 09/11/2015

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: Physician
• Device Catalogue Number: 30-401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention