MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number	KD-V411M-0730
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus medical systems corp.(omsc).The exact cause has been under investigation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
During an endoscopic sphincterotomy (est), the subject device was used.The cutting wire of the subject device broke.The intended procedure was completed with another device.There was no patient injury reported.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The cutting wire of the subject device was broken.The broken section of the cutting wire was melted and burned.As a measurement result of the outer diameter of the cutting wire, there was no abnormality.As a measurement result of the length of the cutting wire and the cutting wire coating, there was no abnormality.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, omsc presumes that the event occurred due to the following mechanism.The cutting wire contacted to the distal part of the endoscope since the rear end of the cutting wire was not extended from the distal end of the endoscope.The subject device was activated, and it caused spark.A part of the cutting wire became extremely hot, resulting in breakage.The above device handling has warned in the instruction manual.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Common Device Name: SINGLE USE 2-LUMEN SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10578539
• Report Number: 8010047-2020-06823
• Device Sequence Number: 2627859
• Product Code: KNS
• UDI-Device Identifier: 04953170382642
• UDI-Public: 04953170382642
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K950166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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-V411M-0730
• Device Lot Number: 04K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1