MAUDE Adverse Event Report: GYRUS ACMI, INC.- ELECTRODE

Model Number 257F6

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.Photo of the electrode and the broken piece placed in a cup which placed in a biohazard bag was provided.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Olympus account representative (rep.) reported the device 257f6 flex electrode failed , fell apart during a therapeutic surgery.It is unknown if the electrode came in contact with another instrument.The piece of electrode fell into the patient and was able to be retrieved using grasper.The reporter believed the surgery performed was a cysto bladder biopsy with fulgeration.The intended procedure according to the reporter was completed.There was no patient harm or injury reported due to the event.No user injury was reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on device return evaluation.The electrode model number 257f6 lot number af was returned for the evaluation.Visual inspection on the as is received condition of the device was performed; noted that the device was not returned in its original packaging.Evaluation identified that the ball tip of the electrode is detached and returned for evaluation as well.Inspection noted the distal end of the electrode was examined under a microscope; burnt char marks were observed on the detached ball tip.The green insulation of the electrode has indications of slightly melted insulation as well as burnt char marks as well.The connector of the electrode has no signs of damage or deformities.The length of the electrode measured from the distal end of the insulation where the ball tip was detached to the connector, the length was measured at approximately 16 inches.The wire of the electrode was still intact with the connector.A device functional tests not performed as this electrode is damaged and the ball tip is detached.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

H4: the device was manufactured in january 2022.Device history record (dhr) provided do not include packaging or labeling operations, for this reason a final manufacture date is not available.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The dhr was reviewed and showed the product met all specifications upon release.Likely manufacture practices did not cause the reported failure.The op seq 70 (continuity test) and 90 (qa inspection) shows all finished units passed acceptance criteria provided in manufacturing procedure mpn-34-042.Based on the investigation, the reported complaint was likely due to mishandling during use.However, the exact root cause of the issue could not be conclusively specified.The instruction for use (ifu-99-0431_dg) states "keep the distal tip of any electrode, probe, laser fiber, or other ancillary device in the field of view at all times when active;" "should a higher power setting than expected be required, gradually increase the power.Note the tissue effect after each increase.If there is little or no change in the tissue effect, stop.Recheck all cables, connections, patient contacts, and irrigation fluid before proceeding.Recheck power setting;" "use only nonconductive irrigation solutions.Do not use saline or lactated ringers;" " refer to the appropriate operating and maintenance manual for the endoscope with which the flexible electrode is to be used for additional cautions and instructions" (warnings, page 2).

• Brand Name: ELECTRODE
• Type of Device: ELECTRODE
• Manufacturer (Section D): GYRUS ACMI, INC.-; 93 north pleasant st.; norwalk OH 44857
• Manufacturer Contact: todd brill ; 93 north pleasant st.; norwalk, OH 44857 ; 5082077661
• MDR Report Key: 15500179
• MDR Text Key: 306291014
• Report Number: 1519132-2022-00018
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2022

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: 257F6
• Device Lot Number: AF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/28/2022
• Supplement Dates Manufacturer Received: 09/30/2022; 10/18/2022
• Supplement Dates FDA Received: 10/11/2022; 11/14/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: GRASPER