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

Model Number	3006
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported.The corners of both the outside box and the inside box were crushed and punctured.It was reported by the customer that two of the 3006 cutting forceps packages were damaged and that they would be returning the entire box as a precautionary measure.The issue found during receipt inspection.There is no patient involvement associated on this reported event.No user injury reported.
Additional Manufacturer Narrative
The customer returned a box of five 3006 cutting forceps (lot fr165213) for evaluation due to " issue of outside box and the inside box were crushed and punctured".The complaint devices were returned in their original packaging.Visual inspection performed and found three out of the five packages damaged.The three damaged packages have cracks on the corner(s) with the sterile barrier broken and compromised.The outer package has creases in certain areas, but no major damage.All labels on the outer packaging match the device packages within.The subject device was not functionally tested as they were left preserved in the received condition as returned from the customer.Based on the device return evaluation, it is possible that the reported issue could be attributed to one of the following; storing, shipping or mishandling.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The dhrs ( device history records) for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Dhr showed no associated ncrs (non conformances), reported scrap or recorded process deviations relating to the reported failure.Based on the evaluation, it is possible that the packaging issue could be attributed to one of the following; storing, shipping or mishandling." even though the devices were not used in operation, the observed failure is a known phenomenon likely a result from shipping/handling.The device ifu recommends to not use any devices that may have been damaged prior to operation.Further, since the dhr review was performed without any notes about defected products, all the devices from this lot shipped out of olympus in good condition.This further points the failure towards "storing, shipping or mishandling" as the evaluation result states.On page 2 of the device ifu (pn0013496_ab), it states: "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 the field performance of this device.

• Brand Name: CUT/FCP,5MM/33CM DES III (5/PK)
• Common Device Name: CUT/FCP,5MM/33CM DES III (5/PK)
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 9600 louisiana avenue north; brooklyn park, MA 55445 ; 9013785969
• MDR Report Key: 12824527
• Report Number: 3011050570-2021-00122
• Device Sequence Number: 4571699
• Product Code: GEI
• UDI-Device Identifier: 00821925035898
• UDI-Public: 00821925035898
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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 Expiration Date: 08/09/2024
• Device Model Number: 3006
• Device Lot Number: FR165213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• 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: 10/25/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown