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	02/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the disposable grasping forceps tore a hole in the packaging when opening in a sterile field.There was a few of the graspers being prepped than the one package involved.The issue occurred during preparation for an unspecified procedure there were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: h8 additional information added to field b5, d8, e2, e3, g2, h3 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The customer's allegation of hole or irregularity found in sealed sterile package (sterility compromised) was not confirmed.Based on the results of the investigation, it is likely that the event occurred due to additional heat sealing on the top of the sterile packages.The first heat-sealed section is in the shape of a mountain.Additional heat seal is linear and applied at the top of the mountain at the first heat-sealed section.Therefore, it is short from the edge of the package to the heat-sealed section.The packages with additional heat sealing have a higher seal strength than those without additional heat sealing.Therefore, the package is difficult to open.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The issue was found during preparation for a therapeutic cystoscopy procedure.

• 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: 18790037
• Report Number: 9614641-2024-00486
• Device Sequence Number: 20915991
• Product Code: PTS
• UDI-Device Identifier: 04953170412059
• UDI-Public: 04953170412059
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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: 3XK
• Was Device Available for Evaluation?: No
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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