MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE GRASPING FORCEPS

Model Number FG-55D

Device Problems Difficult to Open or Close (2921); Material Split, Cut or Torn (4008)

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

Event Date 04/18/2022

Event Type  malfunction  

Event Description

The physician at the user facility reported that during a laparotomy procedure, the subject device was being used to remove common bile duct stones via a cholangioscope (chf-v2), and events such as ¿the wire at the root being cut or the basket being unable to open and close when pulled lightly immediately after opening¿ occurred.The bile duct stones were removed with an alternate device (fg-52d).There was no patient or user injury reported due to the event.The user facility later reported that the same issue occurred twice during the same patient procedure with two different devices of the same model.This report is being submitted for the second device, under the medwatch with patient identifier (b)(6).The report for the first device in this event was submitted under medwatch 8010047-2022-08360, with patient identifier (b)(6).

Manufacturer Narrative

The subject device has been returned to olympus for evaluation and the investigation is in process.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The subject device was returned and an evaluation completed for it.The evaluation confirmed the users complaint.In the replication testing, the following phenomena have been confirmed in the products with greater force to open and close the basket than the standard value: 1) compressive buckling or breakage occur when the basket is opened and closed continuously.2) the basket cannot be opened or closed due to breakage or buckling of the tube.Based on the lot number of the device the manufacturing month and year were reported in h4.The specific date could not be made available at this time.Based on the results of the investigation, the exact cause could not be determined due to the following reasons: 1) since the tubes of the subject devices were broken, a force to open and close the basket could not be inspected.2) the details surrounding the event were unknown.It can be concluded that either the products did not meet the specifications or device handling might have contributed to the reported phenomenon.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) repeatedly operating the ring made the compressively buckled part to stretch and tear.4) due to breakage of the tube, the basket could not be opened.The event can be detected/prevented by following the instructions for use which state the following: 1) "do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion." 2) "never use excessive force to open or close the grasping portion.This could damage the instrument." 3) "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.

Manufacturer Narrative

A review of the device history record found no deviations that could have caused or contributed to the reported issue.

• Brand Name: DISPOSABLE GRASPING FORCEPS
• Type of Device: DISPOSABLE GRASPING FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14488308
• MDR Text Key: 292511049
• Report Number: 8010047-2022-08800
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 04953170375071
• UDI-Public: 04953170375071
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912120
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2022

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
• Device Operator: Health Professional
• Device Model Number: FG-55D
• Device Lot Number: 17K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 07/11/2022; 08/17/2022
• Supplement Dates FDA Received: 08/09/2022; 08/26/2022
• 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
• Patient Sequence Number: 1
• Treatment: OLYMPUS CHF-V2 CHOLEDOCHO VIDEOSCOPE; OLYMPUS FG-52D DISPOSABLE GRASPING FORCEPS