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

Model Number	FG-53SX-1
Medical Device Problem Codes	Break (1069); Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer returned the device for evaluation and repair of the grasping part of the device not opening and closing properly.There is no patient involvement and no harm reported to any patient.Upon evaluation of the returned device, it was observed that there was corrosion foreign material on the forceps at the distal end.The arms of the grasping jaws (a part of the linkage mechanism at the distal end) were broken off.The broken surface indicated brittle fracture due to corrosion.The broken arm was missing.This medwatch is being submitted for the reportable issue of the corrosion foreign material found on the forceps distal end as observed during device evaluation.
Additional Manufacturer Narrative
At the facility, the device is sterilized in an autoclave, but ultrasonic cleaning and lubricant application are unknown.The device is returned and an evaluation completed for it.The user¿s complaint was confirmed.Upon inspection of the device, it was observed that there was corrosion foreign material on the forceps at the distal end.The arms of the grasping jaws (a part of the linkage mechanism at the distal end) were broken off.The broken surface indicated brittle fracture due to corrosion.The broken arm was missing.It is likely that insufficient reprocessing caused corrosion and rust, eventual breakage of the linkage on the distal end.There were no other issues with the device.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to the linkage mechanism being broken.This was presumed to be due to the following: 1.Foreign materials or cleaning solution had left on the arm of the grasping jaws due to insufficient cleaning of the device.2.Residues on the arm of the grasping jaws corroded and decreased its strength.3.A force was applied to the linkage mechanism while handling the device.As a result, the linkage mechanism part where decreased its strength was broken.The instruction manual contains the following description which relates to the reported event: "¿ reprocess the instrument immediately after use, first by immersing it in a neutral, low-foaming, medical grade detergent solution, then following the cleaning and sterilization procedures given in this chapter.Failure to reprocess the instrument immediately after use, or using other than a medical-grade detergent may cause corrosion at the metal parts like the grasping jaws.This could impair the operation of the instrument or cause a part of it to break and/or fall off inside the patient.Lubrication 1.Immerse the insertion portion in the basin containing lubricant for 2 to 3 seconds.2.Remove the instrument from the lubricant.3.Operate the slider to open and close the grasping jaws two or three times.4.Wipe the exterior of the instrument with a clean, dry lint-free cloth and allow the instrument to air dry." olympus will continue to monitor field performance for this device.

• Brand Name: GRASPING FORCEPS
• Common Device Name: 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: 15322870
• Report Number: 9614641-2022-00232
• Device Sequence Number: 20213386
• Product Code: PTS
• UDI-Device Identifier: 04953170049040
• UDI-Public: 04953170049040
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013591
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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-53SX-1
• Device Lot Number: K0Y20-8105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2020
• 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: Unknown