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

Model Number FG-51D

Device Problem Material Twisted/Bent (2981)

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

Event Date 02/03/2022

Event Type  malfunction  

Event Description

The customer reported that, during preparation for an unspecified procedure, the basket of the subject device did not close when tested.Three additional devices were tested with the same result.The procedure was completed using the fifth device that was opened.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).The fourth device is being reported on the medwatch with patient identifier (b)(6).

Manufacturer Narrative

Device manufacturer date: device was manufactured in july 2021.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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 established.The suggested phenomenon was presumed to have been due to either the products did not meet the specifications or device handling.If the reported event was caused by a product that did not meet the specifications, a likely mechanism causing the reported event might be the following: 1.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 (open/close) the basket.2.The tube was buckled compressively near the black tube.3.Due to above description ¿2¿, the basket could not be closed.If the reported event was caused by device handling, a likely mechanism causing the reported event might be the following: 1.The details surrounding the event were not determined.However, the tube was bent at an acute angle.2.The ring was operated under circumstances described above.Therefore, a sliding resistance between the tube and operation wire increased causing compressive buckling of the tube.3.Due to above description ¿2¿, the basket could not be closed.The instuctions for use (ifu) contains the following information in relation to the suggested phenomenon: "·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(PARALLEL BASKET TYPE,3FR.)
• Type of Device: DISPOSABLE GRASPING FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-sh, 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: 15407866
• MDR Text Key: 306416695
• Report Number: 9614641-2022-00299
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 04953170060564
• UDI-Public: 04953170060564
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• 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: 17K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1122-2022
• Patient Sequence Number: 1