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

Model Number	FG-55D
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported to olympus that the basket did not open and the device could not be used.The problem, as reported to olympus, was identified during preparation for use for a bile duct lithotripsy.There was no patient injury, associated with the problem, reported to olympus.Another device of identical model was opened and the basket would not open initially; subsequent attempts to open the basket were successful and the device was used to complete the intended procedure.This is report #1 of 2 due to multiple devices reported - reference report patient identifier #(b)(6) for additional device reported.
Additional Manufacturer Narrative
The suspect device was returned to olympus and evaluated.The reported problem was confirmed; the evaluation found that the basket could not be opened/closed due to a broken outer sheath.The investigation is ongoing and the definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the investigation, possible causes may include the following: either the products did not meet the specifications or device handling might have contributed to the reported phenomenon.A definitive root cause cannot be identified.This issue is covered in the instructions for use: ·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 scopes 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.H4: it was identified that the device was manufactured in february 2021.However, a specific date is not clear.Olympus will continue to monitor the field performance of this device.

• Brand Name: DISPOSABLE GRASPING FORCEPS
• Common Device Name: 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: 14685734
• Report Number: 8010047-2022-09986
• Device Sequence Number: 17347923
• Product Code: FBN
• UDI-Device Identifier: 04953170375071
• UDI-Public: 04953170375071
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K912120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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
• Operator of Device: Health Professional
• Device Model Number: FG-55D
• Device Lot Number: 12K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown