MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number KD-V411M-0730

Device Problems Break (1069); Melted (1385)

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

Event Date 08/07/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.Upon inspection testing of the returned device, the user's request was confirmed.It was discovered, the broken part was charred black and melted.When measured, the outer diameter of the knife wire, no abnormality was found.It was confirmed that the length of the knife wire and wire coating had no defects.No other abnormalities were found.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus, the single use 3-lumen sphincterotome v knife wire broke during surgery.The unknown therapeutic procedure was completed with a similar device.There were no reports of patient harm associated with this event.

Event Description

According to the reporter, the event occurred prior to an endoscopic sphincterotomy (est) procedure.The patient was under sedation, but details are unknown and there was no delay that affected the case.There are no additional details regarding the patient or event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.New information added to the following fields: b5.

Event Description

Correction/ clarification to information provided in the initial report: the subject device was returned to olympus for evaluation.Upon inspection and testing of the device, it was observed that the knife wire was broken when it was activated.This report is being submitted for the malfunction found during evaluation of the device (knife wire broken when activated).

Manufacturer Narrative

This report is being supplemented to correct information provided in the initial medwatch report, and to provide additional information based on the legal manufacturer's final investigation.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 the cutting wire (knife wire) was broken due to following mechanism: 1.The cutting wire where the wire coating was torn came into contact with the distal end of the endoscope when the forceps elevator was raised.2.Under circumstances described above 1, an electric conduction was activated.This caused the cutting wire to become hot instantly at the contact point.As a result, the cutting wire broke.However, a definitive root cause could not be determined.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.

Manufacturer Narrative

This report is being supplemented to provide additional investigation results.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Although a definitive root cause of the torn coating could not be determined, likely factors causing the tear could have been the following: - the knife wire was deformed and the coated portion of the cutting wire has possibly been rubbed due to the effect of contacting a metal area of the endoscope.- it is possible that the slider was slightly pushed causing the cutting wire to deflect.The coated portion of the cutting wire has possibly been rubbed due to the effect of contacting a metal area of the endoscope.Although a definitive root cause of the damaged knife wire could not be determined, a likely cause of the cutting wire breakage might be the following reasons.- the cutting wire where the wire coating was torn came into contact with the distal end of the endoscope when the forceps elevator was raised.- under circumstances described above 1, an electric conduction was activated.This caused the cutting wire to become hot instantly at the contact point.As a result, the cutting wire broke.The customer may be able to reduce and prevent occurrence of the event by handling device in accordance with the following ifu : - 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 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 additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Type of Device: SINGLE USE 2-LUMEN SPHINCTEROTOME
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15361656
• MDR Text Key: 305795781
• Report Number: 9614641-2022-00272
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170184055
• UDI-Public: 04953170184055
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-V411M-0730
• Device Lot Number: 23K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian