MAUDE Adverse Event Report: GYRUS ACMI, INC IGLESIAS WORKING ELEMENT

Model Number EIWE

Device Problem Charred (1086)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus and is currently pending evaluation.Olympus is still investigating this reported event and has followed up with the user facility via telephone and in writing to obtain additional information.The exact cause for the reported event cannot be determined at this time.

Event Description

Olympus was informed that during an unspecified procedure, the surgeon sustained a burn to the hand, while operating the working element.The surgeon inspected the inside of the working element and noted black char where it had burnt.It is unknown if the intended procedure was completed or if the surgeon was medically treated for the burn.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device evaluation.The device was returned to olympus for evaluation.A visual inspection was performed on the received device and found the block actuator charred and burned at the active cord input.A water leak test was performed and the device passed the leak test.The electrode o-ring and rack support o-ring was found intact.The telescope channel passage and locking mechanism were tested and inspected with no anomalies found.Based on the evaluation findings, this type of phenomenon is due to fluids invading the connection block causing an electrical short to occur due to the poor connection of the electrode, working element and cable.The instruction manual warns users ¿insert the pk bipolar working element with assembled telescope and electrode into the appropriate resectoscope sheath by aligning the red dots and snapping together.Failure to properly follow the instructions, warnings, and cautions may lead to serious surgical consequences or injury to the patient.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.¿.

• Brand Name: IGLESIAS WORKING ELEMENT
• Type of Device: IGLESIAS WORKING ELEMENT
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 7033895
• MDR Text Key: 92156271
• Report Number: 2951238-2017-00725
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK951972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EIWE
• Device Catalogue Number: EIWE
• Device Lot Number: BP
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/15/2017
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other