MAUDE Adverse Event Report: GYRUS ACMI INC PKS PLASMA MORCELLATOR; PLASMASORD

Model Number 962000PK

Device Problem Insufficient Information (3190)

Patient Problem Cancer (3262)

Event Date 08/26/2009

Event Type  Injury  

Event Description

Olympus was informed that a patient underwent a laparoscopic hysterectomy bilateral salpingo-oophorectomy procedure using a morcellator.It was alleged that the use of the morcellator led to the upstaging, dissemination, and seeding of malignant cells.At the time of surgery, the patient also had an occult uterine malignancy that was later diagnosed as myxoid leiomyosarcoma.Olympus contacted the user facility via telephone and in writing to obtain additional information regarding the reported event but with no success.

Manufacturer Narrative

No device has been returned to olympus for evaluation.However, olympus cannot conclusively determine the exact cause of the reported phenomenon.Olympus will continue to investigate this report, and if additional significant information becomes available at a later time, this report will be supplemented.The filing of this report is not an admission that the device caused or contributed to the reported event.

• Brand Name: PKS PLASMA MORCELLATOR
• Type of Device: PLASMASORD
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough MA 01772 210
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4842273
• MDR Text Key: 5912346
• Report Number: 2951238-2015-00216
• Device Sequence Number: 1
• Product Code: HET
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 962000PK
• Device Catalogue Number: 962000PK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2015
• 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