MAUDE Adverse Event Report: GYRUS ACMI, INC- BROOKLYN BUGBEE FULGURATING ELECTRODE, 58 CM (2/PKG); ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number BE-558

Device Problem Off-Label Use (1494)

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

Event Type  malfunction  

Event Description

It was reported customer was reusing the disposable item and had asked the facility customer representative (rep.) for reprocessing information and if it had any reusable electrodes.There is no patient infection associated on this reported event.No patient harm or injury reported, no user injury reported due to the event.

Manufacturer Narrative

The subject device was not returned for evaluation, additionally customer does not know and did not provide the lot number of the device.In communication with the customer representative, technical assistance center (tac) support engineer, informed the rep.That the electrodes are disposable item.Tac noted that customer was told that the item is single use and now knows not to reuse the item.In addition, customer was provided a "customer letter" in response to the event reported and the information regarding the correct use of the device per instruction for use (ifu) information.As no device returned, a physical device inspection could not be performed.As the serial/lot was not provided, a device history record (dhr) review could not be completed for the reported complaint device.This single use device is only meant to be used one( 1) time.Multiple uses of the device are against label usage.On page 2 of the device ifu (99-1071_cg), it states: "this product is for single use only.It has not been designed to be reused or resterilized.Reprocessing may lead to changes in material characteristics such as metallic corrosion and dulled edges, ceramic and plastic deformation or splitting which may impact the strength of the device and compromise device performance.Reprocessing of single use devices can also cause cross-contamination leading to patient infection.These risks may potentially affect patient safety." olympus will continue to monitor complaints for this device.

• Brand Name: BUGBEE FULGURATING ELECTRODE, 58 CM (2/PKG)
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC- BROOKLYN; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15127124
• MDR Text Key: 302584066
• Report Number: 3005975494-2022-00021
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00821925038189
• UDI-Public: 00821925038189
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-558
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/01/2022
• 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