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

Model Number FG-53SX-1

Device Problems Device Reprocessing Problem (1091); Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an olympus service center for evaluation and the reported issue was confirmed.When the slider was operated, the grip remained closed and did not open or close.After applying lubricant, the grip was opened and closed smoothly.The arms of the grasping jaws (the linkage mechanism at the distal end) had foreign materials.After removing the foreign material, the grasping jaws opened, but there was a feeling of being caught in the opening and closing.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, during preparation for use for a urological procedure, the grasping forceps grip (jaw) was stiff and did not open.Another grasping forceps was used, however, the same issue occurred.The intended procedure was completed by switching to a spare grasping forceps.The surgical delay was less than five (5) minutes.The patient was not under general anesthesia as the procedure was an outpatient examination.No patient injury reported.The primary cleaning, ultrasonic cleaning, lubrication, and sterilization of the device was implemented according to the recommendations of the instruction manual.In the urology department, the same phenomenon had occurred multiple times in the past.However, the customer did not recall the number of occurrences or dates of the events.The only information provided for the past multiple events was that the issues occurred during an unknown diagnostic procedure.The grasping forceps grip (jaw) was stiff and did not open.The intended procedure was completed by switching to a spare grasping forceps.The surgical delay was less than five (5) minutes.The patient was not under general anesthesia as the procedure was an outpatient examination.During the evaluation of the device, it was noted there was foreign matter was adhered to the forceps.This report is to capture the reportable malfunction of the foreign matter was adhered to the forceps noted at estimation.This complaint is related to patient identifiers: (b)(6) (grasping forceps, fg-53sx-1).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections h6 and h10.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, a definitive root cause could not be determined.However, it is likely due to foreign matter adhesion from insufficient cleaning.The following information is stated in the instructions for use (ifu): ¿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.Lubrication: 1.Immerse the insertion portion in the basin containing lubricant for 2 to 3 seconds.2.Remove the instrument from the lubricant.3.Operate the slider to open and close the grasping jaws two or three times.4.Wipe the exterior of the instrument with a clean, dry lint-free cloth and allow the instrument to air dry.¿ olympus will continue to monitor field performance for this device.

• Brand Name: GRASPING FORCEPS
• Type of Device: GRASPING FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; aomori olympus co., ltd.; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15163719
• MDR Text Key: 304911467
• Report Number: 9614641-2022-00105
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 04953170049040
• UDI-Public: 04953170049040
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

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
• Device Operator: Health Professional
• Device Model Number: FG-53SX-1
• Device Lot Number: K1916-2096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1