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); Peeled/Delaminated (1454)

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

Event Date 08/03/2022

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 coated portion of the cutting wire was torn, and the broken portion was scorched and melted.The outer diameter of the cutting wire was measured and no abnormalities were observed.The length of the cutting wire and the coated portion was measured.The distal side of the coated portion was missing approximately 7.0-9.0mm.There were no abnormalities identified that could have led to the breakage of the cutting wire.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 output was activated while the torn area of the coated portion of the cutting wire was in contact with the distal end of the endoscope while the forceps elevator was raised, causing the cutting wire to become instantly hot, resulting in breakage of the cutting wire.It is likely the coated portion of the cutting wire was torn while the forceps elevator of the endoscope was raised, the slider was pushed more than needed, causing the cutting wire to deflect.The coated portion of the cutting wire and the metal part of the distal end of the endoscope came into contact.Then, the cutting wire was moved back and forth, causing the coated portion of the cutting wire to tear.It is likely that the loss of the wire coating is caused by the wire coating being torn and then falling off due to some load applied to the torn wire coating, such as the load at the time of removal from the endoscope.However, the status of occurrence could not be identified.This might have caused the coated portion of the cutting wire to detach from the cutting wire.As a result, the coated portion was partially missing.However, the exact cause of the reported event could not be identified.The device's instruction manual (drawing no.Gk6224; revision no.8) 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.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.¿ olympus will continue to monitor field performance for this device.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported that during a therapeutic endoscopic sphincterotomy (est) procedure, the tip of the knife wire broke.Reportedly, no fragments fell off.The subject device was reportedly inspected prior to the procedure and no anomalies were observed.Another similar device was used to complete the intended procedure.There was no report of patient or user injury due to the event.

• 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: 15340507
• MDR Text Key: 305817216
• Report Number: 9614641-2022-00257
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• 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
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2022
• 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
• Treatment: HIGH-FREQUENCY DEVICE AMCO (MODEL: UNKNOWN); JF-260V EVIS LUCERA DUODENOVIDEOSCOPE