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	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned for evaluation and the investigation is in progress.The subject device was returned for evaluation and it was found the wire was broken with energization.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
The customer reported the tip of the kd broke off and was stuck in the papilla.The intended endoscopic retrograde cholangiopancreatography procedure was successfully completed using a tjf endoscope.There was an unspecified procedure delay due to removing the broken segment from the papilla.No patient harm or injury reported.The erbe hf device was normal kd settings.No additional information is available.The device was returned for repair.The olympus service center identified the wire was broken with energization.This is a reportable event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the root cause of the broken knife wire could not be identified.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Correction to g3 of the initial medwatch.The aware date should be (b)(6) 2021.Investigation activities have been opened, to manage the actions related to this report and any required mdr reporting.

• 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: 13122382
• Report Number: 8010047-2021-16988
• Device Sequence Number: 19999850
• Product Code: KNS
• UDI-Device Identifier: 04953170382703
• UDI-Public: 04953170382703
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2022

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: 11K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 03/10/2022; 11/08/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 04/08/2022; 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ERBE HF DEVICE
• Patient Sex: Unknown