MAUDE Adverse Event Report: GYRUS ACMI, INC FLEXIBLE FULGURATING ELECTRODE, BALL TIP, 37CM

Model Number 257F8

Device Problem Material Deformation (2976)

Patient Problem Burn(s) (1757)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

As part of our investigation, olympus followed up with the user facility and requested for the return of the device.To date, the device has not been returned to olympus for evaluation.Therefore, the cause of the reported event could not be determined at this time.Olympus will continue to investigate this report and if the device is returned at a later time, this report will be supplemented accordingly.

Event Description

Olympus was informed that during a cystoscopy procedure, 2.5 inches of the bugbee device (257f8) was exposed and burned approximately 0.5cm of the physician¿s hand (dorsum).The physician received local care (topical ointment dressing) to treat the burn.The user facility also reported that the device was inspected prior to use with no anomalies found.No patient injury was reported.

• Brand Name: FLEXIBLE FULGURATING ELECTRODE, BALL TIP, 37CM
• Type of Device: FLEXIBLE FULGURATING ELECTRODE, BALL TIP, 37CM
• 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: 7363408
• MDR Text Key: 103269241
• Report Number: 2951238-2018-00203
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2018

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: 257F8
• Device Catalogue Number: 257F8
• Device Lot Number: CE0344
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/22/2018
• 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): Required Intervention