MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number	KD-V411M-0720
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the cutting wire (knife wire) was out of shape.It was not possible to enter smoothly, and the cutting wire position was not proper.The reported issue was observed during endoscopic retrograde cholangiopancreatography (ercp).The intended procedure was completed using the same device without a delay.There was no patient or user injury reported due to the event.The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, it was observed that the clever cut coating of the knife wire was completely shaved off.This report is being submitted for the malfunction found during device evaluation (coating peeled off and wire exposed).Additional details have been requested regarding the reported issue.At this time, no additional information has been provided.
Additional Manufacturer Narrative
During inspection and testing, it was observed that the wire was slightly deformed.However, the wire position while pushing and pulling was found to be in normal range.The investigation is ongoing; therefore, a definitive 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 legal manufacturer's final investigation.Please see updates to h4, h6 and h10.H4: based on the 3 digit lot number provided, the manufacturing date of the device was in the month of may 2022 but a specific date could not be identified.The customer provided additional information regarding the event.The customer confirmed that the coating portion did not fall off into the patient¿s body.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it¿s likely the slider was slightly pushed causing the cutting wire to deflect.Additionally, it¿s probable the coated portion of the cutting wire rubbed due to the effect of contacting a metal area of the endoscope, and it wound up and retracted into the tube.The final root cause of this event was unable to be identified.The following is included in the instructions for use: ¿do not use excessive force to bend the distal end of the sphincterotome.This could damage the cutting wire.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.When inserting the instrument into the endoscope, hold the slider firmly.Otherwise, the distal end of the insertion portion may bend and could extend from the distal end of the endoscope abruptly.This could cause patient injury, such as perforations, bleeding, or mucous membrane damage.It could also damage the endoscope 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 advance or extend the instrument abruptly.This could cause patient injury, such as perforations, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.When inserting the instrument into the endoscope, hold it close to the biopsy valve and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.Insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.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 sphincterotome 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.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Common Device Name: 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 (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17415525
• Report Number: 9614641-2023-01048
• Device Sequence Number: 18314055
• Product Code: KNS
• UDI-Device Identifier: 04953170184017
• UDI-Public: 04953170184017
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K950166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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-V411M-0720
• Device Lot Number: 25K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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