MAUDE Adverse Event Report: GYRUS ACMI, INC. MULTIDEBRIDER FOOTSWITCH; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number MDFS100

Device Problems Intermittent Continuity (1121); Unexpected Shutdown (4019)

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

Event Date 11/16/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

Event Description

A user facility reported to olympus that while using a multidebrider footswitch during an unspecified procedure while removing polyps, the foot switch was intermittent and then lost all power.The physician was able to use a manual instrument to remove the polyp and there was no impact to the patient's procedure outcome.However, the foot switch issue caused a procedure delay of around 30 minutes while attempting to remedy the situation.Patient identifier (b)(6) is for the multidebrider power console.Patient identifier (b)(6) is for the multidebrider footswitch.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot 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, since the device was not returned for an evaluation, the customer¿s reported complaint could not be confirmed.This supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: MULTIDEBRIDER FOOTSWITCH
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16432617
• MDR Text Key: 310130326
• Report Number: 3003790304-2023-00087
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925027787
• UDI-Public: 00821925027787
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDFS100
• 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: 06/19/2023
• 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
• Treatment: MULTIDEBRIDER POWER CONSOLE
• Patient Outcome(s): Other