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

Model Number	FG-55D
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the tubes of the basket were broken and accumulated.The customer intended to use the device to remove foreign bodies from patient's bronchial tubes.The subject device was sent to an olympus service center for evaluation.During inspection and testing, the basket could not be closed.This report is being submitted for the malfunction found during evaluation (unable to close basket).There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
Device manufacturer date: device was manufactured in may 2021.Specific date of manufacture was not available.During inspection and testing, the basket could not be closed.When the device was received, the grasping portion was closed.The tube was compressively buckled near the black tube.The grasping portion could not be closed by pushing the ring.When the ring was operated by holding the buckled area after the tube was straightened, the grasping portion could not be opened.No deformities were found in the grasping portion and there was not foreign material adhered to the grasping portion.A review of the device history record found no deviations that could have caused or contributed to the damage to the tube.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it can be inferred that either the products did not meet the specifications or device handling might have contributed to the damage to the tube.If the reported event was caused by a product that did not meet specifications, the likely cause may be a force to open and close the basket was greater than the standard value, therefore, a compression force was applied to the tube when operating the basket, the tube buckled compressively near the black tube, and further operation of the device broke the tube.If the reported event was caused by device handling, it is likely that the tube was bent at an acute angle, the ring was operated and the sliding resistance between the tube and operation wire increased causing compressive buckling of the tube.Further operation of the device in that condition broke the tube.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warning, which may help to prevent the issue: "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.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

• 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: 15513414
• Report Number: 9614641-2022-00389
• Device Sequence Number: 5069826
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2022

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: 15K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• 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