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

Model Number	FG-51D
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was sent to olympus for evaluation.The grasping portion was closed when the device was received.The tube was torn near the black tube and the tube near the torn portion was compressively buckled.The grasping portion was unable to extend from the tube by pushing the ring and was unable to open.When the ring was operated by holding the torn area after the tube was straightened, the grasping portion was able to open and close.No deformities were found in the grasping portion and no foreign material had adhered to the grasping portion.During replication testing, the basket was opened and closed by tightly coiling the insertion portion as instructed by the instruction manual warnings.The tube was compressively buckled near the black tube during the first attempt to close the basket.A review of the device history record found no deviations that could have caused or contributed to the damage to the tube.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it can be inferred that either the products did not meet the specifications or device handling might have contributed to the reported event.If the reported event was caused by a product that did not meet specifications, the likely cause may be 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 the basket, the tube buckled compressively near the black tube, and further operation of the device broke the tube which prevented the basket from opening.If the reported event was caused by device handling, it is likely that the tube was bent at an acute angle, the ring was operated and the sliding resistance between the tube and operation wire increased causing compressive buckling of the tube.Further operation of the device in that condition caused the tube to break which prevented the basket from opening.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.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.
Event or Problem Description
An olympus representative reported to olympus, on behalf of the user, prior to an unknown procedure, three disposable grasping forceps could not be opened and/or closed.The procedure was completed with a similar device.It was further reported, this type of procedure takes 14 minutes, however; the start of this procedure was delayed by 30 minutes due to this event.There was no patient harm associated with this event.The first grasping forceps is being reported on the medwatch with patient identifier (b)(6).The second grasping forceps is being reported on the medwatch with patient identifier (b)(6).

• Brand Name: DISPOSABLE GRASPING FORCEPS
• 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: 15392064
• Report Number: 9614641-2022-00284
• Device Sequence Number: 6179261
• Product Code: PTS
• UDI-Device Identifier: 04953170375040
• UDI-Public: 04953170375040
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: CLASS1-EXMPT
• 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,Company Representative
• Initial Reporter Occupation: Pharmacist
• 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-51D
• Device Lot Number: 16K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• 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: 03/01/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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