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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LINA MEDICAL INTERNATIONAL OPERATIONS AG LINA POWER MORCELLATOR; LAPAROSCOPE, GYNECOLOGIC AND ACCESSORIES
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LINA MEDICAL INTERNATIONAL OPERATIONS AG LINA POWER MORCELLATOR; LAPAROSCOPE, GYNECOLOGIC AND ACCESSORIES Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Cancer (3262)
Event Date 07/19/2017
Event Type  Injury  
Event Description
The patient underwent power morcellation using the version of this device manufactured by lina during the course of a robotic myomectomy procedure for symptomatic fibroid disease, assumed to be benign.The procedure was performed at (b)(6) hospital in (b)(6).The patient was not informed of the possibility of a uterine soft tissue sarcoma masquerading as a fibroid disease- despite concerning features and clinical symptoms.The patient was not consented for the use of a power morcellator during the myomectomy operation.Within several months, the patient developed extensive abdominal sarcomatosis and is now battling an advanced stage iatrogenic abdominal sarcomatosis.
 
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Brand Name
LINA POWER MORCELLATOR
Type of Device
LAPAROSCOPE, GYNECOLOGIC AND ACCESSORIES
Manufacturer (Section D)
LINA MEDICAL INTERNATIONAL OPERATIONS AG
MDR Report Key8320285
MDR Text Key136006042
Report NumberMW5083832
Device Sequence Number1
Product Code NWV
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 02/06/2019
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/07/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Other; Required Intervention; Disability;
Patient Age37 YR
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