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

Model Number KD-V411M-0725

Device Problems Break (1069); Melted (1385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.Upon inspection and testing of the device, it was confirmed that the cutting wire (knife wire) was broken.The broken portion was black and melted.The outer diameter of the cutting wire was measured and no abnormalities were observed.The length of the coated portion of the cutting wire, and the length of the cutting wire itself, presented no abnormalities.There were no missing parts in the subject device.There were no abnormalities identified that could have led to the breakage of the cutting wire.Although the customer reported the device had not been used when the broken cutting wire was noted, based on the inspection of the returned device, the sphincterotome had been energized (output was activated).A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the legal manufacturer's investigation, it is likely that the device was not extended enough from the distal end of the endoscope, resulting in the cutting wire and the endoscope being close to each other.Output was then activated, which may have led to an electrical discharge between the cutting wire and the distal end of the endoscope.The electrical discharge would result in the cutting wire becoming instantly hot, resulting in breakage of the cutting wire.The device's instruction manual provides the following warnings which may help to prevent the issue: "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.Do not activate output while the cutting wire touches the metal parts of the endoscope, or they are being close together.This could burn the tissue and/or damage the endoscope or the instrument.¿ olympus will continue to monitor field performance for this device.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

Event Description

The customer reported that the knife wire was found to be broken, before the device was used during an unspecified therapeutic procedure.Another similar device was used to complete the intended procedure.There was no report of patient or user injury due to the event.Additional details have been requested regarding the reported issue.At this time, no additional information has been provided.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14289108
• MDR Text Key: 299671361
• Report Number: 8010047-2022-07630
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170382635
• UDI-Public: 04953170382635
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/04/2022

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
• Device Operator: Health Professional
• Device Model Number: KD-V411M-0725
• Device Lot Number: 1XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1