MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)

Model Number	KD-VC611Q-07301S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
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
Olympus medical systems corp.(omsc) was informed by the health professional that during an endoscopic sphincterotomy (est) using the subject device, the cutting wire was broken.There were no missing parts.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 not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.The manufacturing record was reviewed and found no irregularities.It is possible to infer the cause from the results of past similar investigations, therefore it was determined that an investigation using equipment with similar structure or similar device is unnecessary.Based on the past similar cases, omsc presumes that the event occurred due to the following occurrence mechanism.High frequency current was conducted between the cutting wire and the tissue at the point of contact, or high frequency current was conducted when they were being close to each other.Hight frequency current was conducted between the cutting wire and the distal end of the endoscope at the point of contact, or high frequency current was conducted when they are being close to each other.Due to raising the forceps elevator, the cutting wire at the torn area of the coated portion of the wire and the distal end of the endoscope came into contact.Under these circumstances, high frequency current was conducted.If the reported event had occurred in the case of description ¿c¿, a likely mechanism causing the tear of the coated portion of the wire might be the following: the slider was pushed more than needed causing the cutting wire to deflect.The deflected coated portion of the cutting wire and the metal part of the distal end of the endoscope came into contact when the forceps elevator was raised.The tube was moved back and forth in the situation of description ¿2¿, causing the metal part of the distal end of the endoscope to scratch the coated portion of the wire.As a result, the coated portion of the wire was ruptured.The above device handling has warned in the instruction manual.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)
• Common Device Name: SINGLE USE PRELOADED SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11838944
• Report Number: 8010047-2021-06432
• Device Sequence Number: 14397249
• Product Code: KNS
• UDI-Device Identifier: 04953170399404
• UDI-Public: 04953170399404
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141991
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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: Health Professional
• Device Model Number: KD-VC611Q-07301S
• Device Lot Number: 05V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1