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

Model Number	FG-253SX
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that during a therapeutic removal of ureteral stent procedure the single use grasping forceps did not come out of the package and remained sterile.The plastic side of the package ripped and torn and contaminated the inner item, rendering it unusable.Staff reported that that had been happening more than these two times.The procedure was completed, but it was slowed down by having to open a new grasper.There was no report on patient harm associated with the event.Customer did not have any other packaging.Those disposable graspers were the only option customer was having for removing/changing ureteral stents.Customer had those 2 unusable ones due to poor/defective packaging.This report is related to linked patient identifier (b)(6).
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Please see updates to b3 of the initial medwatch.The device was returned to olympus for inspection, the visual inspection of the physical device under a microscope found no biomaterial or debris on the distal end.The coil sheath is uniform, and handle is intact.Additionally, the rotation grip could rotate the distal end clockwise, and the slider was able to open and close the jaws without an issue.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 reported complaint could not be determined due to packaging was discarded during decontamination process.However, the device is functional and in good condition.Furthermore, the likely cause of the reported event is due to 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 which may have caused the reported event.However, the root cause of the reported event is unable to be determined.The event can be prevented by following the instructions for use (ifu) which state: ·do not store the sterile packages containing the instrument in places where they will be damaged, wet, or improperly sealed.Otherwise, the sterility of the instrument may be compromised and pose an infection control risk or cause tissue irritation.·do not use an instrument if it is dropped before the carton or the package is opened.If the sterilized pack is damaged, the sterility may be compromised.·always have a spare instrument available.Olympus will continue to monitor field performance for this device.

• 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: 18380062
• Report Number: 9614641-2023-01973
• Device Sequence Number: 18042595
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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: 3XK19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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