MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE GRASPING FORCEPS(PARALLEL BASKET TYPE,3FR.)

Model Number	FG-52D
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was discarded by the customer and, therefore, not sent to olympus for evaluation.Attempts to replicate the reported issue using a test device did not result in damage or compressive buckling of the tube after the basket was opened and closed ten times repeatedly after the insertion portion was coiled twice and made smaller than fifteen centimeters in diameter.Since the lot number of the device was not known, a review of the device history record for one year prior to the event was conducted.No deviations were found that could have caused or contributed to the reported event.Olympus only ships devices that meet specifications.Based on the results of the legal manufacturer's investigation, due to condition of the device being unknown and replication testing not replicating damage or compressive buckling of the tube, 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.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.
Event or Problem Description
The customer reported that the basket did not open when extended from the forceps channel during an unspecified procedure.Adjusting the angulation of the scope did not result in the basket opening.The procedure was completed with another similar device.There was no effect on the patient due to the event.

• Brand Name: DISPOSABLE GRASPING FORCEPS(PARALLEL BASKET TYPE,3FR.)
• Common Device Name: DISPOSABLE GRASPING FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15393360
• Report Number: 9614641-2022-00288
• Device Sequence Number: 6124294
• Product Code: EOQ
• UDI-Device Identifier: 04953170060595
• UDI-Public: 04953170060595
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2022
• Initial Report FDA Received Date: 09/09/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: URF-P7: OLYMPUS URETERO-RENO-FIBERSCOPE.
• Patient Sex: Unknown