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

Model Number EIWE

Device Problems Electrical /Electronic Property Problem (1198); Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

There is no additional information for this event as yet.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this event, during set up for a trans urethral resection of bladder tumor (turbt) procedure the device had a burn mark where the cord attaches to the device.Set up was completed with another similar device to perform the procedure.There was no patient involvement and no adverse impact to any patient.

Manufacturer Narrative

The device is not returned.As such, an actual device evaluation is not performed.An evaluation is done based on historical records.This supplemental report is being submitted to provide this information.The device history record review was not possible to perform as the production lot was not provided.Manufacture date is also not available as the lot number is no known.The customer reported that the device had a burn mark where a bovie cord attached to the it.The user's request was not confirmed as the device was not returned for evaluation.Reported event is a known phenomenon.A spark occurring as an active cord is being connected to hand piece is often due to intermittent connection of the cord or use of a cord other than those specified.Page 16 of the device instructions for use (ifu) indicates that the device shall be used with a dac (dac: usa elite system¿ and usa series¿ disposable active cord) and a uca (universal active cord adapter.The ifu states "caution: the use of cords other than those specified may result in increased emissions or decreased immunity of the medical electrical equipment." as reported by the customer, a bovie cord was used with the device instead of dac / uca.The use of this unspecified cord possibly contributed to reported event.However, with limited information provided, a root cause could not be determined.

• Brand Name: IGLESIAS WORKING ELEMENT
• Type of Device: CYSTOURETHROSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10550517
• MDR Text Key: 207548334
• Report Number: 1519132-2020-00074
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• PMA/PMN Number: K951972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

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: No Information
• Device Model Number: EIWE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 11/24/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1