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

Model Number MDFS100

Device Problem Blocked Connection (2888)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/22/2023

Event Type  Injury  

Event Description

Olympus further received information that the intended procedure was functional endoscopic sinus surgery (fess).The bleeding was resolved by cautery.The device was inspected before use with no visible issues.No other information was provided.

Manufacturer Narrative

This reports is being supplemented to provide additional information from customer.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, the footswitch was faulty and caused the connection issue.This supplemental report includes information added to h4.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.; 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: 17396221
• MDR Text Key: 336675548
• Report Number: 3011050570-2023-00093
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925027787
• UDI-Public: 00821925027787
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123429
• 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: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 273798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 07/28/2023; 01/10/2024
• Supplement Dates FDA Received: 08/09/2023; 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2014
• 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
• Patient Outcome(s): Required Intervention; Other