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

Model Number	FG-47L-1
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated by olympus.The evaluation found that the broken arms had brown foreign material around the broken area.Additional evaluation findings are as follows: 1.) the grasping jaws did not open or close when the slider was operated; 2.) the arms of the grasping jaws were broken off; 3.) the broken surface indicated brittle fracture due to corrosion; 4.) the broken arm was missing.The investigation is ongoing and the definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
A user facility returned the olympus, model fg-47l-1, grasping forceps, to olympus due to a report that the tip grip was broken at the coil sheath connection.The problem, as reported to olympus, was identified during preparation for use.There was no patient injury, associated with the event, reported to olympus.Upon evaluation of the device, contamination was noted around the broken area.This report is submitted due to the finding that contamination was present, identified during the olympus evaluation of the returned device.As the problem was found during in-house evaluation of the device, there was no patient involvement.
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 likely cause of the broken linkage mechanism might be 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 following is included in the instructions for use (ifu): "after using this instrument, reprocess and store it according to the instructions in chapter 4, ¿reprocessing¿ and chapter 5, ¿storage¿.Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance." "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" "ultrasonic cleaning 1.Immerse the insertion portion in the ultrasonic cleaner containing detergent solution.2.Connect a 10 cm3 (10 ml) syringe filled with detergent solution to the reprocessing port.3.Depress the plunger to inject 10 cm3 (10 ml) of detergent solution into the insertion portion.If it is not possible to inject the detergent solution or if it leaks from any areas other than the distal end of the insertion portion and/or in the vicinity of the slider, do not use the instrument.4.Disconnect the syringe from the reprocessing port.5.Immerse the entire instrument in the detergent solution.6.Clean ultrasonically for 30 minutes.For details on operation of the ultrasonic cleaner, refer to the instruction manual of the ultrasonic cleaner.7.Remove the instrument from the detergent solution." 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: 15473909
• Report Number: 9614641-2022-00351
• Device Sequence Number: 2892143
• Product Code: EOQ
• UDI-Device Identifier: 04953170031625
• UDI-Public: 04953170031625
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962485
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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-47L-1
• Device Lot Number: K1908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• 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