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

Model Number KD-V631M-07202S

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2021

Event Type  malfunction  

Manufacturer Narrative

In speaking olympus technical services, the reporter had only called in to report the complaint.No technical assistance was performed.Additional information was requested from the reporter.A supplemental report will be submitted should additional information be made available.The subject device referenced in this report was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported by the customer, during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure, the cutting wire popped off the single use preloaded sphincterotome v.The doctor was able to finish the procedure.No patient harm reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the reporter and the results of the legal manufacturer¿s investigation.The legal manufacturer performed an investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The device was manufactured in june 2020.The root cause of the issue could not be conclusively specified.Based on the similar complaint investigation results in the past, a likely mechanism causing the detachment of the cutting wire might be the following.1) the cutting wire was too close to the tissue or endoscope.2) the output was activated in a state of 2¿ description instead of ¿1¿ description.3) during activation, accidental discharge might have occurred at two points in the cutting wire at the same time.4) the discharge caused the cutting wire to become hot instantly.As a result, the cutting wire was broken and detached.The instructions for use (ifu) provides the following guidelines: ¿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.¿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.Corrected data: e2/e3/g2.

Event Description

Additional information was received from the reporter.The issue occurred in the middle of the procedure.The same device was not used to complete the procedure.The device was inspected prior to use and was working properly.

• Brand Name: SINGLE USE PRELOADED SPHINCTEROTOME V
• Type of Device: SINGLE USE PRELOADED SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12376871
• MDR Text Key: 268471370
• Report Number: 8010047-2021-10833
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170403187
• UDI-Public: 04953170403187
• Combination Product (y/n): N
• PMA/PMN Number: K122505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-V631M-07202S
• Device Lot Number: 06V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1