MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. GRASPING FORCEPS

Model Number	FG-53SX-1
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
Event or Problem Description
The customer reported that his olympus grasping forceps was experiencing a problem with the tip of the forceps opening poorly.The customer went on to confirm the device¿s reprocessing steps before noting that this issue occurs every 2-3 months at their facility.The customer confirmed that this event did not result in any patient harm.This report is being submitted to capture the insufficient reprocessing noted by the customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.D9, h3, and h6 were updated to include information about the device being returned and evaluated.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 root cause of the suggested event could not be concluded, although it can be presumed that the defect was caused due to the lubricant not being applied properly and some foreign materials remaining because the appropriate reprocessing was not performed according to the instruction manual.The event can be detected/prevented by following the warnings in the instructions for use: "¿ reprocess the instrument immediately after use, first by immersing it in a neutral, low-foaming, medical grade detergent solution, then following the cleaning and sterilization procedures given in this chapter.Failure to reprocess the instrument immediately after use, or using other than a medical-grade detergent may cause corrosion at the metal parts like the grasping jaws.This could impair the operation of the instrument or cause a part of it to break and/or fall off inside the patient.·after use, do not leave the product with dirt on it; wash it immediately.Also, when cleaning, use a low-foaming and neutral cleaning solution for medical devices.If you leave the product dirty after use or use an unspecified cleaning solution, corrosion may occur on the metal parts such as the grip, which may cause parts near the grip to fall off or the grip to not close during use." 4.3 cleaning: ultrasonic cleaning.1.Immerse the entire instrument in the ultrasonic cleaner containing detergent solution.2.Clean ultrasonically for 30 minutes.For details on operation of the ultrasonic cleaner, refer to the instruction manual of the ultrasonic cleaner.3.Remove the instrument from the detergent solution.4.3 cleaning: ultrasonic cleaning.1.Immerse the entire grasping forceps in the cleaning solution of the ultrasonic cleaner.2.Ultrasonic cleaning for 30 minutes.For instructions on how to use an ultrasonic cleaner, please follow the attached document or electronic version of the attached document or instruction manual for the ultrasonic cleaner.3.Remove the grasping forceps from the cleaning solution.Olympus will continue to monitor field performance for this device.

• Brand Name: GRASPING FORCEPS
• Common Device Name: 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: 17460262
• Report Number: 9614641-2023-01088
• Device Sequence Number: 7153150
• Product Code: PTS
• UDI-Device Identifier: 04953170049040
• UDI-Public: 04953170049040
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013591
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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-53SX-1
• Device Lot Number: K3113-5682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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