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

Model Number	KD-V431M-0730
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus¿s local distributor, but not returned to omsc.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
We received the following report from the health professional.During an endoscopic sphincterotomy (est), the subject device was used.The blade of the subject device broke after activating the output several times (towards the end of the procedure).The intended procedure was completed with another device.There was no patient injury reported.A photo of the subject device was provided and broken knife wire was confirmed.
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 was broken.Investigation was carried out to confirm the broken portion.The coated portion of the cutting wire was torn, and the broken portion was scorched and melted.The outer diameter of the cutting wire was measured.The result indicated no abnormalities.The length of the cutting wire and the coated portion was measured.The distal side of the coated portion was missing approximately 5.0-6.0 mm.Other abnormalities were not found in the device.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 occurrence mechanism.The cutting wire was out of a torn area of the coated portion while the forceps elevator of the endoscope was being up.As a result, the cutting wire had contact with the distal end of the endoscope.In the state of being ¿1¿, the electric conduction was activated.The temperature of the cutting wire instantly became very high at the contact point.This caused the cutting wire to break.It has been confirmed that the tear of the coated portion of the cutting wire could duplicate by the following mechanism.The forceps elevator of the endoscope was raised.When the cutting wire deflects, the coated portion of the cutting wire and the metal part of the distal end of the endoscope come into contact.In state of description ¿2¿, the cutting wire was moved back and forth.This caused the coated portion of the cutting wire to tear.The slider was pushed more than needed.This caused the cutting wire to deflect.It can be inferred that some kind of force might have applied to the coated portion of the cutting wire when the device was withdrawn from endoscope after the coated portion of the cutting wire has torn.This might have caused the coated portion of the cutting wire to detach from the cutting wire.As a result, the coated portion was partially missing.However, the exact cause of the reported event could not be identified.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: 11383409
• Report Number: 8010047-2021-03036
• Device Sequence Number: 14417523
• Product Code: KNS
• UDI-Device Identifier: 04953170184192
• UDI-Public: 04953170184192
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K950166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: No Information
• Device Model Number: KD-V431M-0730
• Device Lot Number: 91V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1