MAUDE Adverse Event Report: GYRUS ACMI, INC FLEXIBLE FULGURATING ELECTRODE, CONICAL TIP, 37CM; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number 256F8

Device Problems Break (1069); Material Separation (1562)

Patient Problem Electric Shock (2554)

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported after an unspecified procedure using a monopolar active cord with a bugbee electrode, when the electrode was disconnected from the active cord, the electrode was in so tightly that the active cord broke.The unit worked normally for the entire procedure, and the procedure was completed successfully.When the doctor attempted to disconnect the electrode from the active cord, it was incredibly difficult.When the physician pulled the electrode out, the active cord was damaged.The blue protective coating broke off the cord, and at this the area of the cord, the physician experienced an electrical shock.The physician required no treatment for the shock experienced.

Manufacturer Narrative

This report is being submitted to provide corrected information.Corrected information is reported in d1, d4 (model and udi), and d10.

Manufacturer Narrative

This report is being updated to provide investigation findings.New information is reported in h6 and h10.The lot number was unknown.The device was not returned, but a photo of the referenced device was provided.The provided photo does not contain the entire device, the picture of the electrode tip was not taken.Reviewing the provided photo shows that the model is 256f8 (not 257f8).The date code cannot be seen, so the lot number remains unknown.The blue sheath was completely detached from the electrode.No signs of cut, crack or burning were observed on the sheath.Connector body and wire are intact, undamaged.A device history record (dhr) review could not be performed because the lot number is unknown.Olympus does not ship any device that does not meet all design and safety specifications.The instructions for use shipped with the device provided the user with the following information regarding the reported event: study this manual and other labeling thoroughly for safe handling and storage.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Conclusion: due to no device return, a root cause of the reported complaint cannot be determined at this time.

• Brand Name: FLEXIBLE FULGURATING ELECTRODE, CONICAL TIP, 37CM
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11901470
• MDR Text Key: 262189952
• Report Number: 1519132-2021-00010
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00821925008700
• UDI-Public: 00821925008700
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2021

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: 256F8
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 05/28/2021
• Supplement Dates Manufacturer Received: 06/21/2021; 07/09/2021
• Supplement Dates FDA Received: 06/22/2021; 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 80100291; BUGBEE ELECTRODE (257F8)