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
Event or Problem Description
The olympus representative reported to olympus on behalf of the customer that upon opening the package to use, it would only rip into tiny pieces and the grasper became contaminated on the single use grasping forceps fg-253sx during the therapeutic stent removal procedure.The 2nd grasper had the same issue; however, they were able to use it.The 2nd grasper had the same packaging issue.The procedure was completed with another similar device.The issue reported did not impact the outcome of the procedure.There were no reports of patient harm or impact associated with the reported event.This report is linked to patient identifier: (b)(6).
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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.Correction to d9 device return date and h3 device inspection.The packaging for fg-253sx was returned; however, the physical device was not returned.An inspection cannot be carried out.Correction to section e for information inadvertently left out of previous report.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: 18070801
• Report Number: 9614641-2023-01657
• Device Sequence Number: 20749489
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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: 38000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 11/05/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown