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

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

Device manufacturer date: the device was manufactured in march 2019 based on the three-digit lot information.The exact date could not be determined with only the three-digit lot number.During inspection and testing, the basket could not be closed.Upon inspection, it was discovered the outer sheath was detached and kinked which exposed the metallic wire near the protective tube.It was also noted the pipe inside the handle was broken.However, the slider and handle looked to be good condition without any visual damage.During a functional check, when the slider was manipulated, the grasping portion would not retract into the distal.A review of the device history record found no deviations that could have caused or contributed to the failure of the basket closure.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, the tube appeared compressively buckled near the black tube.It is likely the basket could not be moved due to compressive buckling of the tube, not breakage of the operating pipe.It can be inferred that either the product did not meet the specifications or device handling might have contributed to the breakage of the tube.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: 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.The tube was buckled compressively near the black tube and the basket could not be manipulated.If the reported event was caused by device handling, a likely mechanism causing the reported event might be the following: the tube was bent at an acute angle and the ring was operated.Therefore, a sliding resistance between the tube and operation wire increased causing compressive buckling of the tube and the basket could not be manipulated.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.

Event Description

The customer reported the basket on the subject device did not open during use in a bronchoscopy procedure.The procedure was completed using a similar device.The subject device was sent to olympus 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.

• Brand Name: DISPOSABLE GRASPING FORCEPS
• 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 (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15950507
• MDR Text Key: 308073188
• Report Number: 9614641-2022-00741
• Device Sequence Number: 1
• Product Code: PTS
• UDI-Device Identifier: 14953170375047
• UDI-Public: 04953170375040
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS1-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• 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: 93K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1