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

Model Number	KD-V411M-0330
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.According to the provided picture, omsc confirmed that the cutting wire was broken off but could not find other abnormalities.The manufacturing record was reviewed and found no irregularities.Based on the picture of the device and the similar cases in the past indicates that the cause of the breakage of the wire might be in one of the following causes.An electrical discharge possibly occurred, and the cutting wire became hot instantly.That have caused the cutting wire to break.High frequency current was conducted between the exposed cutting wire and the tissue at the point of contact or the devices being closed to each other.High frequency current was conducted between the cutting wire and the distal end of the endoscope at the point of contact or the devices being closed to each other.C) high frequency current was conducted in the state of the coated portion of the cutting wire being torn, and the metal part of the forceps elevator were contacted while the forceps elevator was up.In the case of ¿c¿, a likely cause of the tear of the coated portion might be the following reasons.The slider was pushed more than needed.That have caused the cutting wire to deflect.The deflected coated portion of the cutting wire, and the metal part of the forceps elevator were came into contact while the forceps elevator was up.The tube was moved back and forth as a state of description ¿2¿.It can be assumed that the coated portion of the wire was scratched and torn from the effect of contacting the metal part of the forceps elevator.The above device handling has warned in the instruction manual.
Event or Problem Description
We received the following report.During an endoscopic sphincterotomy (est), the subject device was used.The cutting wire of the subject device was torn off during the cutting or dilation of the papilla.The intended procedure was completed with another device.There was no patient injury reported.

• 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: 10668372
• Report Number: 8010047-2020-07592
• Device Sequence Number: 16881199
• Product Code: KNS
• UDI-Device Identifier: 04953170382611
• UDI-Public: 04953170382611
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K950166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: No Information
• Device Model Number: KD-V411M-0330
• Device Lot Number: 9ZV
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2020
• Initial 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