MAUDE Adverse Event Report: GYRUS ACMI INC. ROLLER BAR

Model Number ROLLER BAR

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 06/15/2015

Event Type  Injury  

Event Description

Olympus was informed that during a therapeutic endometrial ablation procedure for uterine bleeding, the patient was burned and sustained a small (superficial) blister on the inside of the labia upon withdrawal of the instrument from the uterus.It was stated that there was no bleeding observed at the burn site.The patient was provided a cream for the burn and will follow up with the physician at a later date.The intended procedure was completed with the same device.The device was inspected after the procedure and it appeared that the insulation on the exterior portion of the loop was peeling.No further information was provided.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the patient's outcome could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the user facility that the device referenced in the report was discarded after use in the procedure.Therefore, no device will be returned to olympus for investigation.

• Brand Name: ROLLER BAR
• Type of Device: ROLLER BAR
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01772 2104
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4918991
• MDR Text Key: 6031629
• Report Number: 2951238-2015-00313
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ROLLER BAR
• Device Catalogue Number: ROLLER BAR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other