MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN NEEDLE KNIFE V

Model Number	KD-V441M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus medical systems corp.(omsc) for evaluation.In the evaluation of omsc the following was confirmed, the lot number was 0yk with supplementary information number of "12".The broken portion was scorched and melted.The cutting knife of the device side was broken at the distal end of the tube.The broken portion of the cutting knife was scorched and melted.The outer diameter of the cutting knife was measured.The result indicated no abnormalities.The length of the coated portion of the cutting knife, and the cutting knife itself presented no abnormalities.There were no missing parts in the subject device.Other abnormalities that could lead to the breakage of the cutting knife were not confirmed.No abnormalities were detected in the device history record with the lot number for the following inspection items which related to the reported phenomenon.Appearance of cutting wire.Length of cutting wire parts.Operation of cutting wire.Based on the confirmation result of the subject device, it is possible that the following factors might have caused the electrical discharge that led to the breakage of the cutting knife.The cutting knife had not been kept on moving.The length of contact between the tissue and the cutting knife was short.The output activation time was long.The setting value for the output activation was high.The above device handling has warned in the instruction manual.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from user facility that the cutting knife broke and fell off during the endoscopic retrograde cholangiopancreatography (ercp) procedure.The user facility states that the non-olympus generator vio300 setting was the same as usual and not changed.The user facility recovered the dropped part during the procedure, the intended procedure was completed with another device.There was no report of patient injury associated with the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The event can be prevented by following the instructions for use which state: ·always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures.Excessive output level and time may result in patient injury, such as perforation, bleeding, or mucous membrane damage.·when applying output, keep moving the cutting knife.When the knife stops and touches tissue at a point, concentrated electric current could cause the distal tip of the knife to dissolve and come off in the body.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE 3-LUMEN NEEDLE KNIFE V
• Common Device Name: SINGLE USE 3-LUMEN NEEDLE KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12581903
• Report Number: 8010047-2021-12776
• Device Sequence Number: 3787888
• Product Code: KNS
• UDI-Device Identifier: 04953170244124
• UDI-Public: 04953170244124
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955247
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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: KD-V441M
• Device Lot Number: 0YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2020
• 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