MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED)

Model Number	KD-VC631Q-07301S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that while using the single use preloaded sphincterotome v (distal wireguided), the cutting wire broke.The issue occurred during the endoscopic retrograde cholangiopancreatography (ercp) procedure, there was no delay, and the therapeutic procedure was completed with a similar device.There was no patient harm associated with the event.
Additional Manufacturer Narrative
The device was reportedly discarded and is not expected to be returned for evaluation.The subject device was manufactured in july 2022 (within 2 years of reported event) based on the provided 3-digit lot information.However, the manufacture date could not be identified since the subject device was not returned.The device history record for the lot indicated no anomaly with the event-related items.The record includes the following.Process inspection sheet.Quality inspection sheet.Nonconforming product report.The event can be detected/prevented by following the instructions for use which state: before use, prepare and inspect the instrument and a cord as instructed below.Should any irregularity be observed, do not use the instrument or a cord; use a spare instead.Damage or irregularity may compromise patient or user safety, pose an infection control risk, cause tissue irritation, perforations, bleeding, mucous membrane damage, thermal injury, and may result in more severe equipment damage.Do not use excessive force to bend the distal end of the sphincterotome.This could damage the cutting wire.Do not operate the sphincterotome if the insertion portion is bent or the distal end of the tube is straight.This could damage the tube.Do not move the slider rapidly.This could damage the sphincterotome.Do not stretch the cutting wire too tightly.This could damage the instrument.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.·do not insert the instrument into the endoscope when the cutting wire is tightened.Doing so may extend the distal end of the insertion portion from the endoscope tip abruptly.This could cause patient injury, such as perforations, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.Do not force the instrument if resistance to insertion is encountered.Reduce the angulation or lower the forceps elevator of the endoscope until the instrument passes smoothly.The use of excessive force could cause patient injury, such as perforations, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.Do not tighten the cutting wire more than necessary, and do not force it against the papilla of vater.This could result in patient injury, such as perforations, bleeding, or mucous membrane damage.Do not withdraw the instrument from the endoscope while the cutting wire is tightened.This could damage the endoscope or instrument.The exact cause of the reported phenomenon could not be conclusively identified by the following reason: ·the device was not returned for the investigation.·the device history record for the lot indicated no anomaly with the event-related items.Based on the investigation result of the similar complaint in the past, it can be inferred that an excessive force was applied to the cutting wire after it was bent near the distal tip.This might have caused the cutting wire to break and fall off.However, the circumstances surrounding the event were unclear, and the exact cause could not be determined.Although the root cause of this event could not be determined, olympus will continue to monitor field performance for this device, and take appropriate actions as necessary.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED)
• Common Device Name: SINGLE USE PRELOADED SPHINCTEROTOME
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15977016
• Report Number: 9614641-2022-00765
• Device Sequence Number: 20556572
• Product Code: KNS
• UDI-Device Identifier: 04953170371493
• UDI-Public: 04953170371493
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2022

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-VC631Q-07301S
• Device Lot Number: 27V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown