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

Model Number	FG-52D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during a procedure, the blue-on-black handle coating on the subject device sprung open and the device could no longer be used.A second device of the same model was opened, and the same issue occurred.A third device of the same model was then used to complete the intended procedure without issue.There was no patient or user injury reported due to the event.This report is being submitted for the issue with the second device, under the medwatch with patient identifier (b)(6).The issue with the first device is being submitted on the medwatch with patient identifier (b)(6).
Additional Manufacturer Narrative
The subject device was discarded by the user facility.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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.H4: august 2019 a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.The root cause could not be determined.Additional details surrounding the event were unable to be obtained from the customer.In the replication testing in the past, damage or compressive buckling of the tube was not replicated.The event can be detected/prevented by following the instructions for use which state: ·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.Olympus will continue to monitor 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: 14488050
• Report Number: 8010047-2022-08797
• Device Sequence Number: 14654772
• Product Code: EOQ
• UDI-Device Identifier: 04953170375057
• UDI-Public: 04953170375057
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K962378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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-52D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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