MAUDE Adverse Event Report: GYRUS ACMI, INC UNKNOWN; MORCELLATOR

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

There was no specific model of morcellator provided, and the letter was served to other manufacturers of morcellators.The cause of the reported event could not be confirmed.If additional information becomes available, this report will be supplemented accordingly.The filing of this report is not an admission that the device caused or contributed to the reported event.

Event Description

Olympus received a legal document which states, in 2007 a patient underwent a laparoscopic myomectomy and hysterectomy procedure with the use of an unidentified power morcellator.The legal document indicates; as a result of the use of the power morcellator, the patient developed leiomyosarcoma.Cancer.It was also noted, that prior to undergoing surgery, the patient was not warned of the high-risk that the use of a laparoscopic power morcellator could cause the spread and recurrence cancer.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 2951238-2019-00739.The product was not returned and the model number could not be confirmed.962000pk is a placeholder model number as it is the only morcellator product that olympus has manufactured at the time of the legal file reports.No device history record review could be done as the model number was not confirmed and were unable to obtain a serial/lot number.The root cause cannot be determined.Olympus will continue to monitor the field performance of this device.

• Brand Name: UNKNOWN
• Type of Device: MORCELLATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8507525
• MDR Text Key: 141734061
• Report Number: 2951238-2019-00739
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR