MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE PRELOADED SPHINCTEROTOME V

Model Number	KD-V631M-07201S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported to olympus that during an endoscopic retrograde cholangiopancreatogram procedure, the wire broke.There was no patient injury, associated with the problem, reported to olympus.
Additional Manufacturer Narrative
The suspect device was returned to olympus, however, an evaluation has not been completed at this time.The investigation is ongoing and the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device evaluation confirmed the reported device problem.Visual inspection revealed that the distal end of the guidewire, where the cutting wire was located, was damaged and detached.The distal end of the guidewire was examined under a microscope and the cutting wire was found to be completely detached from the plastic portion of the distal end.The coated portion of the cutting wire was not torn, and no parts of it were missing.However, the cutting wire exhibited burn/char marks consistent with its use.The coated portion of the cutting wire was also inspected, and the evaluators did not observe any damage/missing portions.However, a kink was located near the v marking.The handle was also inspected, and cracks were found.Functional tests could not be performed on the device as the cutting wire on the distal end of the guidewire was damaged.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported device problem.A definitive root cause for the reported product problem was not established.However, it was probable that the issue occurred according to the following mechanism: the cutting wire was pulled tightly when the distal end of the tube had not adequately deflected.As a result, a tensile load was applied to the press fitted area of the distal tip.This caused the distal tip to detach from the tube.The occurrence of the reported incident can be prevented by adhering to the instructions for use (ifu), which state the following: ¿do not use excessive force to bend the distal end of the sphincterotome.This could damage the cutting wire.Do not stretch the cutting wire too tightly.This could damage the sphincterotome.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 sphincterotome.Do not withdraw the instrument from the endoscope while the cutting wire is tightened.This could damage the endoscope or instrument." olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V
• 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: 14287779
• Report Number: 8010047-2022-07607
• Device Sequence Number: 11152921
• Product Code: KNS
• UDI-Device Identifier: 04953170403163
• UDI-Public: 04953170403163
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K122505
• 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,Followup
• Report Date (Section B): 07/15/2022

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-V631M-07201S
• Device Lot Number: 15V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 07/15/2022
• 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
• Patient Sex: Unknown