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

Model Number KD-V411M-0725

Device Problem Break (1069)

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

Event Date 08/08/2022

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 that could lead to breakage of the knife wire could be confirmed.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.The following medwatch reports are related: patient identifiers (b)(6) (kd-v411m-0725) and (b)(6) (kd-v411m-0725, this complaint).

Event Description

The customer reported to olympus, the single use 3-lumen sphincterotome v knife wire broke when it was energized immediately after use in a procedure.The same problem occurred with the replacement product.The procedure was completed with the third replacement which caused a 5-10 minute delay.There were no reports of patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented 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.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, although the exact cause could not be identified, a likely mechanism causing the broken cutting wire may be due to the following: 1.The cutting wire at a torn area of the coated portion came into contact with the distal end of the endoscope while the forceps elevator was raised.2.The output was activated in state of ¿1¿ description, and the cutting wire became hot instantly.This caused the cutting wire to break.In addition, it has been confirmed that the tear of the coated portion of the cutting wire could be duplicated by the following: 1.The forceps elevator of the endoscope was raised.2.When the cutting wire deflects, the coated portion of the cutting wire and the metal part of the distal end of the endoscope come into contact.3.In state of description ¿2¿, the cutting wire was moved back and forth.This caused the coated portion of the cutting wire to tear.The slider was pushed more than needed.This caused the cutting wire to deflect.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿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.¿ ¿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.¿ this supplemental report includes information added to d8 and g2.Olympus will continue to monitor field performance for 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: 15362458
• MDR Text Key: 303642006
• Report Number: 9614641-2022-00274
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170184031
• UDI-Public: 04953170184031
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

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-0725
• Device Lot Number: 22K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2022
• 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