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

Model Number KD-V411M-0320

Device Problems Device Damaged Prior to Use (2284); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during an unspecified procedure, the vater papilla was cannulated and during cutting, the device sphincterotome wire burst.The user replaced the device with a non olympus electrosurgical unit brand ¿conmed¿ model ¿exalibur plus.The serial number of the device used not provided.There were no further detail provided regarding the event.No known patient harm or injury reported.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.The following sections were updated: g4, g7, h2, h4, h6, and h10.The suspect device was not returned to olympus for evaluation.The lot number ¿9yk¿ provided indicates that the device was manufactured in nov 2019.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.The instruction manual contains the following information: since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the cutting wire is very short, the output is too high or activated while the cutting wire touches metal parts of the endoscope, or the cutting wire is tightened too strong.When the cutting wire breaks off, its proximal end will be retracted toward the endoscope if the slider is pulled.If the slider is pushed, the cutting wire will be pushed out toward the papilla or move sideways.If the cutting wire breaks off, stop the output immediately and pull the slider completely to retract the broken cutting wire into the tube.Then withdraw the sphincterotome from the papilla.Otherwise, patient injury, such as perforations, bleeding, or lacerations within the biliary duct, and/or damage of the endoscope could result.Be sure that the rear end of the cutting wire is extended from the distal end of the endoscope.In case the cutting wire contacts the forceps elevator, insufficient output or unintended tissue injury may occur.When inserting the instrument into the endoscope, be sure that the cutting wire is parallel to the tube.Otherwise, the metal part of the forceps elevator may contact the cutting wire and peel off the coating material.Do not activate output while tissue is in contact with the torn or damaged coated portion of the distal end.If output is activated while tissue is contacting the torn or damaged coated portion due to insertion into or withdrawal from an endoscope, leakage current, decreased output, and/or thermal injury could result.If you feel the cutting is blunt, withdraw the device from the scope to examine if there is any peel off and tear at the coating portion.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Type of Device: 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: 10734618
• MDR Text Key: 224488183
• Report Number: 8010047-2020-08158
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170382604
• UDI-Public: 04953170382604
• Combination Product (y/n): N
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-V411M-0320
• Device Lot Number: 9YK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1