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

Model Number	FG-44NR-1
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that, during reprocessing of the subject device, a brown rust-like substance was found floating in the cleaning liquid after the device was immersed.The user determined the substance derived from the subject device.The person in charge of the facility pointed out that the subject device rusted quickly and deteriorated faster than other reusable treatment tools.The subject device was not used and there was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
Initial reporter name: establishment name: (b)(6).The suspect device was sent to olympus for evaluation.The brown floating material was not sent.The insertion tube was buckled approximately 150 millimeters from the tip.The tip of the forceps was discolored brown and part of the tip was corroded.Cleaning the device with an ultrasonic cleaning machine did not change the dark brown part at the tip of the device and did not generate any floating matter.Because there was corrosion on the tips of the device which could not be removed by rubbing, the dark brown spots on the tips of the device were judged to be rust.The facility reported using purax cleaning liquid for immersion, but the instruction manual directs the use of neutral cleaning liquid for immersion.Purax contains sodium hypochlorite which is strongly alkaline.A review of the device history record found no deviations that could have caused or contributed to the corrosion and rust.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it was not possible to identify the brown suspended matter which occurred during reprocessing at the facility since no matter was generated from ultrasonic cleaning.It is likely the corrosion of the tip of the forceps was due to lack of cleaning after use which resulted in foreign matter and cleaning fluid remaining which caused corrosion.Also use of a non-neutral cleaning solution and age of the device are likely factors as the useful life of this product is one year after manufacture and shipment.It was also noted that materials and usage differ depending on the product which causes the speed of deterioration to vary from product to product.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: "before use, check that there is no corrosion (fine holes, dents, discoloration, etc.) on the gripping part and that the gripping part can be opened and closed smoothly.Gripping forceps with corrosion on the gripping part or abnormal operation should not be used.Doing so may damage the grip, causing the grip to fall out into the body cavity or prevent the grip from closing.Discontinue use immediately.If the grasping forceps cannot be pulled into the endoscope channel, pull out the endoscope together with care not to damage the inside of the body cavity.If it falls off, use a spare grasping forceps to retrieve it." "after use, wash immediately without leaving dirt on the product.Also, when cleaning, use a low-foaming, neutral cleaning solution for medical equipment.If the product is left dirty after use, or if a non-specified cleaning solution is used, the metal parts such as the grip may corrode, and parts near the grip may fall off or the grip may not close during use." "immersion cleaning solution: use a low-foaming, neutral medical cleaning solution.Follow the instruction manual of the cleaning liquid for the concentration, temperature, immersion time, etc." 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.

• Brand Name: ROTATABLE GRASPING FORCEPS
• Common Device Name: ROTATABLE 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: 15424221
• Report Number: 9614641-2022-00312
• Device Sequence Number: 7529492
• Product Code: EOQ
• UDI-Device Identifier: 04953170032196
• UDI-Public: 04953170032196
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962533
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/14/2022

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-44NR-1
• Device Lot Number: K8Y29-0142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2022
• 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: 04/17/2022
• Initial Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose