MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE PRELOADED SPHINCTEROTOME

Model Number	KD-VC411Q-0720
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
It is reported in the literature article titled "percutaneous transhepatic placement of plastic biliary stents: technical description and preliminary results, " one patient experienced cholangitis (requiring intervention).This was a prospective cohort single-arm single-center pilot study aimed to evaluate the feasibility and safety of percutaneous transhepatic (pth) placement of a plastic biliary stent (pbs) in patients with benign or malignant symptomatic obstructive jaundice (soj).Thirty-two patients with soj were included in the study and evaluated for technical success, clinical success and any complications and were followed-up between 30 and 60 days after stenting for the presence of stent occlusion.The study revealed a 100% and 93.7% technical and clinical success, respectively with 2 observed complications: transient haemobilia (which resolved without intervention) and cholangitis requiring antibiotic therapy and prolonged hospitalization.Hence the study concluded the placement of pbs by pth access was safe, effective, and feasible.The authoring physician confirmed these adverse effects occurred after the pbs 3-month follow-up exam using a clevercut 3v sphincterotome and a tjf-150 duodenoscope.The physician further confirmed there was no malfunction of either the tjf-150 or the clevercut 3v sphincterotome.

• Brand Name: SINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED)
• 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
• MDR Report Key: 12377186
• Report Number: 8010047-2021-10839
• Device Sequence Number: 11737838
• Product Code: KNS
• UDI-Device Identifier: 04953170371110
• UDI-Public: 04953170371110
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: KD-VC411Q-0720
• 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: 08/02/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TJF-150
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention