MAUDE Adverse Event Report: GYRUS ACMI, INC. CUT/FCP,5MM/33CM DES III (5/PK); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 3006

Device Problems Shipping Damage or Problem (1570); Defective Component (2292)

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

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported to olympus, the cut/fcp, 5mm/33cm des iii (05/pk) was reported to fail upon installation; the sterile package was compromised.The bottom tab was broken off, and the other was crimped in.There were no reports of patient injury or medical intervention associated with this event.Related patient identifier: (b)(6) to capture the two other sterile packages that were compromised.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.Upon visual inspection, it was found that one plastic corner of each package was damaged, appearing folded and cracked, thereby compromising the sterile barrier.No foreign material or debris was observed inside the packages.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the damage to the packages resulted from transportation mishandling, such as excessive force applied to the box during shipping or accidental dropping of the device packages.The event can be prevented by following the instructions for use (ifu) which state: "before surgery_1) carefully remove the device from its shipping package.Inspect to ensure no damage has occurred during transit or storage.Do not use this device if the packaging or device is damaged." olympus will continue to monitor field performance for this device.

• Brand Name: CUT/FCP,5MM/33CM DES III (5/PK)
• 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: 18401301
• MDR Text Key: 331676957
• Report Number: 3011050570-2023-00235
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925035898
• UDI-Public: 00821925035898
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3006
• Device Lot Number: FR305537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2023
• 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