MAUDE Adverse Event Report: GYRUS ACMI, INC. PK FRONT LOAD,IGLESIAS,WORKING ELEMENT; RESECTOSCOPE, WORKING ELEMENT

Model Number EIWE-PKFL

Device Problem Fire (1245)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

The customer reported to olympus, the pk front load, (b)(6), working element caught fire during an unspecified therapeutic procedure.There were no reports of patient harm.

Manufacturer Narrative

The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide the legal manufacturer's final investigation and additional information provided in e2, e3.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the reported complaint could not be confirmed as the device was not returned.Olympus reached out to the customer for additional information regarding the reported incident, including details about where the device caught fire, the timing, associated devices, and generator & power settings.However, the customer only mentioned that the fire happened on the actuator block where an electrode was inserted into the working element, the suspect device was discarded, and its serial/lot number was unknown.No further details or information were provided.The following factors may have impacted the device: a worn block actuator, retained moisture in the actuator block, a defective snap-in lock mechanism, or short circuit between connector and electrode due to saline leakage.The specific root cause can not be determined at this time due to limited information and the unavailability of the subject device for inspection.Olympus will continue to monitor field performance for this device.This report is related to mfr # 3011050570-2024-00101 for the device that was used during the same procedure.

• Brand Name: PK FRONT LOAD,IGLESIAS,WORKING ELEMENT
• Type of Device: RESECTOSCOPE, WORKING ELEMENT
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18592929
• MDR Text Key: 333897439
• Report Number: 3011050570-2024-00028
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 00821925011229
• UDI-Public: 00821925011229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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: EIWE-PKFL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/28/2024
• Supplement Dates Manufacturer Received: 03/03/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1