MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME

Model Number	KD-401Q-0730
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus medical systems corp.(omsc).The cutting wire of the subject device was broken off.The broken section of the cutting wire was melted and burned.As a measurement result of the outer diameter of the cutting wire, there was no abnormality.There were no missing parts.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, omsc assumes that the cutting wire broke since the tube was insufficiently protruded from the endoscope and the cutting wire was too close to the endoscope while the device was activated, and it caused spark.Then, a part of the cutting wire became extremely hot, resulting in breakage.The above device handling has warned in the instruction manual as follows.*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.When the wire breaks off, its proximal end will be retracted toward the endoscope if the slider is pulled.If the slider is pushed, the wire will be pushed out toward the papilla or move sideways.If the wire breaks off, stop the output immediately and pull the slider completely to retract the broken wire into the tube.Then withdraw the instrument from the papilla.Otherwise, patient injury, such as perforations, bleeding, or lacerations within the biliary duct and/or damage of the endoscope could result.
Event or Problem Description
We received the following report.During a biliary procedure and papilla cutting, the subject device was used.The cutting wire broke.Another device was then used without any problem.There was no patient injury reported.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.On september 16, 2020, olympus medical systems corp.(omsc) found that the cutting wire was broken off, and that the broken section of the cutting wire was melted and burned.

• Brand Name: DISPOSABLE TRIPLE LUMEN SPHINCTEROTOME
• Common Device Name: DISPOSABLE TRIPLE 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: 10653557
• Report Number: 8010047-2020-07436
• Device Sequence Number: 3219986
• Product Code: KNS
• UDI-Device Identifier: 04953170041709
• UDI-Public: 04953170041709
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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-401Q-0730
• Device Lot Number: 01K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1