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

Model Number	KD-V431M-0720
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 single use 3-lumen sphincterotome v (kd-v431m-0720) was returned to the service center for evaluation for the reported event of cutting wire was cut in the center.The returned condition device was visually inspected and the complaint was confirmed.The observation that the metal cutting wire was broken/detached at the flexible distal end.Additionally, the device was inspected under a microscope and observed to have charred marks/dark stains on the wire, which was indicated to be consistent with energy output.No other damages were observed during the inspection.Based upon the evaluation of the returned device, the reported complaint was confirmed and determined to most likely be attributed to device mishandling, in which the cutting wire may have come into contact with a metallic object, resulting in the damages observed.According to the instruction manual, the following statements were provided to the operator to caution during usage; ¿since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the wire is very short, the output is too high or activated while the wire touches metal parts of the endoscope, or the wire is tightened too strong can results in the cutting wire breakage¿.
Event or Problem Description
The service center was informed that one single use 3-lumen sphincterotome v cutting wire (kd-v431m-0720) was observed to be cut in the center when the wire was removed from the scope.The physician was performing a therapeutic endoscopic retrograde cholangiopancreatography (ercp) when the physician requested that the technician bend the tome.It was reported there was no response to the distal end as it was not bending.Upon removal of the device, the observation was made that the center of the cutting wire was separated/detached.It was reported the physician completed the procedure as normally and there was no reported patient injury.

• 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: 9527485
• Report Number: 8010047-2019-04666
• Device Sequence Number: 10865689
• Product Code: KNS
• UDI-Device Identifier: 04953170382680
• UDI-Public: 04953170382680
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K950166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/27/2019

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-V431M-0720
• Device Lot Number: 95V 02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1