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

Model Number	KD-VC631Q-07201S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 - the lot number of the subject device has not been provided at this time.The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the single use preloaded sphincterotome v (distal wireguided) cutting wire broke at the distal end.The cable was felt to be severed when the handle was manipulated.The issue occurred during procedure and the intended procedure was sphincterotomy.There were no reports of patient harm.Related patient identifiers: (b)(6) and (b)(6).
Additional Manufacturer Narrative
The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.A definitive root cause was not established as the device(s) were not returned for evaluation.However, based on the results of previous legal manufacturer investigations, likely causes for the broken cutting wire are: 1) the device was energized in one of these following situations.(a) the cutting wire is in point contact with tissue.Or they were being close to each other.(b) the cutting wire is in point contact with distal end of endoscope.Or they were being close to each other.(c) when the forceps elevator was raised, the cutting wire where the wire coating was torn came into contact with the distal end of the endoscope or they were too close to each other.2) an electrical discharge occurred in the cutting wire, and the cutting wire became hot instantly.3) the cutting wire was broken.If the reported event had occurred in the case of description ¿c¿, a likely factor causing tears of the coated portion of the cutting wire might be the following: ·it is possible that the slider was slightly pushed causing the cutting wire to deflect.The coated portion of the cutting wire has possibly been rubbed due to the effect of contacting a metal area of the endoscope.The occurrence of the reported problem can be prevented by adhering to the instructions for use ¿when inserting or removing this product from the endoscope, pull the slider slightly to advance or retract the knife wire along the curvature of the tube.If the forceps base part of the endoscope is advanced or retracted with the knife wire deflected, the metal part of the forceps base may come in contact with the knife wire, possibly shaving the coating.¿ ¿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.¿ 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.¿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 activating output, set the output mode of the electrosurgical unit to ¿cut¿ or ¿blend¿.Activating output in the ¿coagulation¿ mode could break the cutting wire.¿do not activate output when the distal end of the endoscope is too close to or in contact with body cavity tissue.This could burn the tissue and/or damage the endoscope." olympus will continue to monitor the field performance of this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17393639
• Report Number: 9614641-2023-01033
• Device Sequence Number: 2531180
• Product Code: KNS
• UDI-Device Identifier: 04953170399466
• UDI-Public: 04953170399466
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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-VC631Q-07201S
• Was Device Available for Evaluation?: No
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/15/2023
• 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