MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)

Model Number	KD-VC611Q-07301S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device kd-vc611q-07301s was returned for evaluation.The lot number was 15v with supplementary information number of ¿12¿.(m-bc manufacture date: may 12, 2021).Device evaluation, the following were noted: the cutting wire was broken.The broken portion was scorched and melted.The outer diameter of the cutting wire was measured.The result indicated no abnormalities.The length of the coated portion of the cutting wire, and the cutting wire itself presented no abnormalities.There were no missing parts in the subject device.No other abnormalities were confirmed except the breakage of the cutting wire.The following device history record with the lot no.15v12 of the subject device was confirmed.No abnormalities found from the device history record of the items which relate to the reported phenomenon.-process inspection sheet, -quality inspection sheet, -nonconforming product report.(ifu) instruction for use: this instruction manual (drawing no.Gk9051 rev.10) contains the following information.Therefore, it would be possible to prevent this event from occurring.¿ since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the wire is very short, the output is too high or activated while the wire touches metal parts of the endoscope, or the wire is tightened too strong.When the wire breaks off, its proximal end will be retracted toward the endoscope if the slider is pulled.If the slider is pushed, the wire will be pushed out toward the papilla or move sideways.If the wire breaks off, stop the output immediately and pull the slider completely to retract the broken wire into the tube.Then withdraw the instrument 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.Based on the confirmation result, it can be determined that the cutting wire was broken while the output was activated.Based on the confirmation result and the investigation results in the past, a likely mechanism causing the broken cutting wire might be the following.1.The device was not protruded enough from the endoscope until the rear end of the cutting wire was in the field of view.2.Due to the situation of ¿1¿ description, the cutting wire and the endoscope were being close to each other.3.The output was activated in state of ¿2¿ description.This might have led to an electrical discharge between the cutting wire and the distal end of the endoscope.4.An electrical discharge possibly occurred, and the cutting wire became hot instantly.That might have caused the cutting wire to break.Olympus will continue to monitor complaints for this device.
Event or Problem Description
It was reported that the customer was about to commence with the ercp (endoscopic retrograde cholangiopancreatography) therapeutic procedure , during insertion, customer has noticed that the sharp burst of insertion may have kinked the tip of sphincterotome.When approaching the mucosa, they have noticed that there was "something sticking out" and thought it was the guidewire.The guidewire was pulled out and inspected but there was no fault.The sphincterotome was then pulled out and inspected and saw that the cutting wire has been broken.The customer believes that it was due to the sharp insertion of the item through the biopsy channel.The device was replaced and the intended procedure was completed using similar device (brand new sphincterotome with the same specification).There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
Correction to g3 of the initial medwatch.The aware date should be 15-nov-2021.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)
• Common Device Name: SINGLE USE PRELOADED 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: 14738995
• Report Number: 8010047-2022-10299
• Device Sequence Number: 2123016
• Product Code: KNS
• UDI-Device Identifier: 04953170399404
• UDI-Public: 04953170399404
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2022

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
• Operator of Device: Health Professional
• Device Model Number: KD-VC611Q-07301S
• Device Lot Number: 15V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE
• Patient Sex: Unknown