MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE GRASPING FORCEPS(PARALLEL BASKET TYPE,3FR.)

Model Number FG-51D

Device Problem Difficult to Open or Close (2921)

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

Event Type  malfunction  

Manufacturer Narrative

The suspect device was sent to olympus for evaluation.The device was returned with the grasping portion closed.The tube was found to be compressively buckled near the black tube and was broken.When the ring was pushed, the broken tube with the operating wire was moved into the distal side of the device.Therefore, it was not possible for the grasping portion to extend from the tube and to open.When the broken portion of the tube was fixed by grasping it, the grasping portion was able to open and close by operating the ring.No deformities or foreign substances were found on the grasping section.A review of the device history record found no deviations that could have caused or contributed to the basket not closing.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the basket would not close because the tube was bent at an acute angle and ring was operated.Therefore, a sliding resistance between the tube and operation wire increased causing compressive buckling of the tube.Repeatedly operating the ring made caused the compressively buckled part stretch and break.Due to the compressive buckling or breakage of the tube, the basket was unable to close.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: "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." the device's instruction manual provides the following cautions, 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." 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.

Event Description

The customer reported that, during a procedure, when trying to open the basket of the subject device, the handle moved but the basket did not move and could not be closed.The procedure was completed by collecting the basket and replacing it with another product.There was no effect on the patient due to the event.

• Brand Name: DISPOSABLE GRASPING FORCEPS(PARALLEL BASKET TYPE,3FR.)
• Type of Device: 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: 15245637
• MDR Text Key: 305515196
• Report Number: 9614641-2022-00147
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 04953170078934
• UDI-Public: 04953170078934
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS1-EXMPT
• 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
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-51D
• Device Lot Number: 8XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1