MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE GRASPING FORCEPS FG-253SX; DISPOSABLE GRASPING FORCEPS

Model Number	FG-253SX
Medical Device Problem Codes	Contamination (1120); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.
Event or Problem Description
An olympus senior sales representative reported on behalf of the customer that two single use grasping forceps fg-253sx had packaging problems.The initial package was too flimsy / sealed too tightly.It would only rip into tiny pieces and the grasper became contaminated and the second grasper had the same issue.However, they were able to use it.The issue was found during a therapeutic stent removal procedure.There were no reports of patient or user harm associated with this event.Related patient identifier: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.During the inspection, olympus found the front side of the clear plastic on the package was torn/ripped.There was no damages of the back side of the device package.The original carton of the package was opened.The physical device was also inspected and there were no signs of external damage or foreign residue with the physical device.The subject device was manufactured in july 2023, but the specific date is unknown.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, the sterile packages that are additionally heat-sealed have a higher seal strength than those that are not additionally heat-sealed.Therefore, the sterile packages with additional heat sealing are difficult to open.Therefore, this may have caused the reported event.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being submitted to update the lot number and manufacturing date.

• Brand Name: SINGLE USE GRASPING FORCEPS FG-253SX
• Common Device Name: DISPOSABLE GRASPING FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18088378
• Report Number: 9614641-2023-01668
• Device Sequence Number: 17831176
• Product Code: PTS
• UDI-Device Identifier: 04953170412059
• UDI-Public: 04953170412059
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2023

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: FG-253SX
• Device Lot Number: 37K 24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• 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: Not provided
• Supplement Date Received by Manufacturer: 11/13/2023; 12/05/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 11/28/2023; 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2023
• 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