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

Model Number	FG-52D
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
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 second device.The first 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
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.
Additional Manufacturer Narrative
H4: from the lot number provided the manufacturing date was in february 2021 however the exact date could not be provided.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A device of a similar lot was used for replication testing where: 1.Open the basket.2.Coil the insert portion twice and make it smaller than 15 cm in diameter.3.Operate (open and close) the basket repeatedly. the tube of the subject device was winding at 70-80 cm from the distal end.The winding tube had four waves.Therefore, the procedure was as follows: 1.Open the basket.2.Wrap the tube around the pen 4 times at 70¿80 cm from the distal end of the tube.3.Operate (open and close) the basket repeatedly. the basket was opened and closed 10 times according to each procedure.However, deformation or compressive buckling of the tube did not replicate.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Due to the following reasons stated below, the exact cause of the reported phenomenon (the blue catheter is broken at the top of the handle.As a result, the basket could no longer be retracted/extended) could not be determined.·replication testing was implemented.However, deformation or compressive buckling of the tube did not replicate.·the details surrounding the event were unknown.·since no abnormalities were detected in the dhr, it is inferred that the subject device did not have abnormalities.The following is included in the instructions for use (ifu): "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." 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: 15411422
• Report Number: 9614641-2022-00301
• Device Sequence Number: 20243831
• Product Code: EOQ
• UDI-Device Identifier: 04953170375057
• UDI-Public: 04953170375057
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K962378
• 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): 11/03/2022

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-52D
• Device Lot Number: 12K
• 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: 10/05/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/03/2022
• 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