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

Model Number FG-55D

Device Problem Mechanical Problem (1384)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 09/26/2021

Event Type  Injury  

Event Description

The customer reports during a bronchoscopic intervention procedure using disposable grasping forceps, the cable swirled up and the grasper does not close at the front.This occurred with a total of five graspers from the same batch (lot).This caused a delay in the procedure resulting in a decline in the patient¿s condition.The procedure was completed with a different forceps device and no further consequences to the patient.Additional details regarding the patient and reported event have been requested.At this time, no further information has been provided.Case with patient identifier (b)(6) reports device 1 of 5; case with patient identifier (b)(6) reports device 2 of 5; case with patient identifier (b)(6) reports device 3 of 5; case with patient identifier (b)(6) reports device 4 of 5; case with patient identifier (b)(6) reports device 5 of 5.

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Manufacturer Narrative

This report is being updated to provide additional information reported by the customer.New information is reported in b5.

Event Description

Update: additional information reported by the customer: unfortunately, i cannot provide information regarding what interventions were required due to the patient¿s deterioration of health condition, these interventions were performed by the anesthesiologist.The patient¿s current condition is well, discharged.All five baskets failed during the same procedure.The blue cable was coiled up, but not broken off.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 03oct2021.This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review and applicable correction.New information added to the following fields: a2, a3, h4, h6, h10.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause cannot be identified as the subject device was not returned to olympus for evaluation.The pictures of the device were provided, therefore the investigation was conducted based on the pictures.It was determined from the picture provided, the basket could not be closed due to compressive buckling of the tube.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to the product not meeting specifications or a device handling issue.A likely mechanism causing the reported event might be the following if the event was due to the product not meeting specifications: 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 during the procedure.A likely mechanism causing the reported event might be the following if the event was due to a device handling issue: 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 the description stated above 2, the basket could not be closed during the procedure.The instructions for use state the following: "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 the field performance of the device.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• 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: 13683749
• MDR Text Key: 291307678
• Report Number: 8010047-2022-04008
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 04953170375071
• UDI-Public: 04953170375071
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-55D
• Device Lot Number: 13K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2022
• Initial Date FDA Received: 03/07/2022
• Supplement Dates Manufacturer Received: 03/11/2022; 05/31/2022
• Supplement Dates FDA Received: 04/07/2022; 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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: UNSPECIFIED BRONCHOSCOPE
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 4 YR
• Patient Sex: Male