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

Model Number	FG-55D
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was sent to an olympus service center for evaluation.Inspection and testing found the basket could not be closed due to a broken/kinked outer sheath.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.
Event or Problem Description
The customer reported that, during preparation for an unspecified procedure, the catheter was broken at the top of the handle and the basket could not be retracted or extended.Two additional devices were opened and tested with the same result.There was no effect on the patient due to the event.This report is for the first device.The second device is being reported on the medwatch with patient identifier (b)(6).The third device is being reported on the medwatch with patient identifier (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.During testing, the returned tube had compressively buckled and was torn.The grasping portion was unable to retract into the tube when the ring was pulled.The grasping section was unable to close even though this portion was not torn.However, when the ring was operated by holding the broken area after the tube was straightened, the grasping portion was able to open and close.A review of the device history record (dhr) found no deviations that could have caused or contributed to the problem described above.The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause for this issue was not established.However, it is probable that the issue occurred because a compressive force beyond the standard value was applied to open and close the basket.The repetitive excessive force was thought to have caused the proximal end of the tube to buckle and eventually tear/break.The occurrence of the reported problem can be prevented by adhering to the instructions for use (ifu) which states the following: ¿·do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.·never use excessive force to open or close the grasping portion.This could damage the instrument.·when the grasping portion does not open and/or close smoothly, do not apply force but set the scope¿s angle back, or move the position of the grasping portion until the basket opens and closes smoothly.If the action is forced, the tube may stretch and the resistance of the handle may increase.Also the calculus may not be retrieved, and/or the grasping portion with calculus engaged may not be removed from the body.¿ olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE GRASPING FORCEPS
• 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15411398
• Report Number: 9614641-2022-00300
• Device Sequence Number: 17521006
• Product Code: KTI
• UDI-Device Identifier: 04953170375071
• UDI-Public: 04953170375071
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K912120
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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
• Operator of Device: Health Professional
• Device Model Number: FG-55D
• Device Lot Number: 95K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• 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: 01/20/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• 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