MAUDE Adverse Event Report: GYRUS ACMI, INC. CUT/FCP,5MM/33CM DES III (5/PK); FORCEPS

Model Number	3006
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus while preparing for use, the cut/fcp,5mm/33cm des iii (5/pk) taken out of the case and the edge is damaged and exposed to air.There were no reports of patient harm associated with this event.
Additional Manufacturer Narrative
The device has been received to date.However, the evaluation is anticipated, but has not begun yet.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned in the original packaging.Two of the corners of the packaging were cracked and damaged, which exposed the handpiece.Several cracks were observed near the handle portion on the plastic packaging.The sterile white paper seal had no signs of puncture, water damage, or tears.The label on the sterile white paper seal had no indications of damage as it was still legible.The device inside of the packaging was in good condition with no signs of damage to the distal end, as well as the handle or loose parts inside of the packaging.Based on the evaluation, the most possible cause of the issue could likely be attributed to damage during transportation or storage.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿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)
• Common Device Name: FORCEPS
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15735217
• Report Number: 3011050570-2022-00121
• Device Sequence Number: 17733477
• Product Code: KGE
• UDI-Device Identifier: 00821925035898
• UDI-Public: 00821925035898
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K023492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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
• Operator of Device: Health Professional
• Device Model Number: 3006
• Device Lot Number: FR234887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown