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 Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus medical systems corp.(omsc).The cutting wire was snapped.The snapped section of the cutting wire got burnt and melted.The outer diameter of the cutting wire was measured : no abnormality was found.The length of the coated portion was measured : no abnormality was found.Breakage on the cutting wire likely occurred by the following mechanism; the coated portion was peeled off.A high frequency current was output while the cutting wire, exposed, was in point contact or close with/to the distal end of the endoscope.A spark occurred between the cutting wire and the distal end of the endoscope.As a result, the cutting wire was instantaneously heated to a high temperature and broke off.The shaving of the wire coating likely occurred by the following mechanism; #1.The cutting wire was loosened as the slider was in the slightly-pushed position.#2.When the forceps elevator of the endoscope was raised, the coating of the loosened cutting wire came in contact with the metal part of the endoscope¿s distal end.#3.The tube was then moved back and forth under the condition of #2.This caused the wire coating to be rubbed with the metal part and shaved off.The above device handling has warned in the instruction.
Event or Problem Description
We received the following report.It was impossible to slide the sphincterotome (the subject device) over the guidewire.There was no patient injury reported.No further information was provided.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.On august 31, 2020, olympus medical systems corp.(omsc) found that the cutting wire was snapped, and that the broken section of the cutting wire was melted and burned.

• 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: 10753446
• Report Number: 8010047-2020-08269
• Device Sequence Number: 14363804
• Product Code: KNS
• UDI-Device Identifier: 04953170371332
• UDI-Public: 04953170371332
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141991
• 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): 10/29/2020

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-VC611Q-07301S
• Device Lot Number: 9YV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1