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

Model Number	FB-21K-1
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the connection between the device cup and the wire came off, and the cup could not be opened or closed.The reported issue occurred at preparation for use.There was no patient involvement on this reported issue.No harm was reported.No patient harm, no user injury reported.Device evaluation , foreign material (brown foreign material ) as described by service repair found around the broken arms of the device.This report is being submitted due to the finding of foreign material around the broken arms of the device identified during device return evaluation.
Additional Manufacturer Narrative
The subject device was received and evaluated.Device evaluation , the following were noted : the model name was fb-21k-1.The lot# was " k2921" and the identification# was " 2672".The grasping jaws did not open or close when the slider was operated.The arm of the cups (a part of the linkage mechanism at the distal end) were broken off.The broken arms had brown foreign materials around the broken place.The broken arms were not missing.The broken surface indicated brittle fracture due to corrosion.The insertion portion was kinked at a position of about 1260mm and 1300mm from the tip.There were no other abnormalities that could lead to the reported issue.The tilt of the cup confirmed the reported issue.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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, the root cause of the event was unable to be identified; however, adherence of foreign matter was confirmed during pre-use inspection likely due to insufficient cleaning after use.The event can be detected/prevented by following the instructions for use which state: 1) "before use, check that there is no corrosion (microscopic holes, dents, discoloration) on the tip and that the cup can be opened and closed smoothly.Biopsy forceps with corroded tips or biopsy forceps that do not open and close the cup smoothly may cause parts to fall off or the cup to become impossible to open and close.In the unlikely event that a part falls off during use or the cup cannot be opened and closed smoothly, immediately stop using it and withdraw the entire endoscope, taking care not to damage the inside of the body cavity.In addition, use a grasping forceps or the like to collect the dropped parts." 2) "after use, do not leave the product with dirt on it, and wash it immediately.Use a low-foaming, neutral medical detergent for cleaning.If the product is left dirty after use, or if non-designated detergent is used, the metal parts such as the cup may corrode, and the parts near the cup may fall off or the cup may not be able to be opened or closed during use." 3) "before use, confirm that the distal tip of the forceps is not corroded, dented or discolored, and that the cups can be opened and closed smoothly.Using forceps that are damaged or not working properly may result in one or more of its components falling off inside the patient.If a component falls off the distal end, or if operation of the cups suddenly becomes more difficult, immediately stop the procedure.Carefully withdraw the forceps together with the endoscope to avoid causing injury within the body cavity.Retrieve any parts that have fallen off inside the patient using another grasping forceps." 4) "reprocess the instrument immediately after use by immersing it in a neutral, low-foaming, medical-grade detergent solution, then following the cleaning and sterilization procedures in this chapter.Failure to reprocess the instrument immediately after use, or using another type of detergent may cause corrosion at the instrument¿s distal end.This could cause components to fall off during use and may interfere with operation of the cups." olympus will continue to monitor field performance for this device.

• Brand Name: BIOPSY FORCEPS
• Common Device Name: BIOPSY FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16483741
• Report Number: 9614641-2023-00319
• Device Sequence Number: 6919394
• Product Code: EOQ
• UDI-Device Identifier: 04953170029776
• UDI-Public: 04953170029776
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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: FB-21K-1
• Device Lot Number: K2921-2672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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