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 Problem Break (1069)

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

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned for evaluation.The customer discarded device.Review of dhr's (device history records) for the lots 12v through 21v* were conducted since the lot number of the device was not provided.The review revealed the lots had passed all the inspections relating to the reported incident.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.*these lots were manufactured one year before the event date.Process inspection sheet.Quality inspection sheet.Nonconforming product report.Ifu (instruction for use) : this instruction manual contains the following information.(drawing no.(b)(4) revision no.13).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.Conclusion summary : the subject device was not returned to olympus.Therefore, the condition of the device could not be confirmed.However, based on the similar complaint investigation results in the past the cause of the breakage of the wire might be in one of the following states.An electrical discharge possibly occurred, and the cutting wire became hot instantly and caused the cutting wire to break.A) high frequency current was conducted between the cutting wire and the distal end of the endoscope at the point of contact or the devices being closed to each other.B) high frequency current was conducted in the state of the coated portion of the cutting wire being torn, and the metal part of the forceps elevator were contacted while the forceps elevator was up.In the case of ¿b¿, a likely cause of the tear of the coated portion might be the following reasons.1) the slider was pushed more than needed.That have caused the cutting wire to deflect.2) the deflected coated portion of the cutting wire, and the metal part of the forceps elevator were came into contact while the forceps elevator was up.3) the tube was moved back and forth as a state of description ¿2¿.It can be assumed that the coated portion of the wire was scratched and torn from the effect of contacting the metal part of the forceps elevator.Olympus will continue to monitor complaints for this device.

Event Description

It was reported that during a therapeutic procedure, when using the device, it was found that the knife wire was broken.The device was replaced and the intended procedure was completed with similar device.There was no patient harm or injury reported due to the event.No user injury reported.

• 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: 14023029
• MDR Text Key: 298400467
• Report Number: 8010047-2022-05795
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170184031
• UDI-Public: 04953170184031
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 81 YR
• Patient Sex: Female