MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number	KD-V411M-0320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature article: "a rare but lethal complication: post-endoscopic retrograde cholangiopancreatography cerebral arterial gas embolism" by hin san chow et al.Iatrogenic air embolism is a rare and potentially fatal complication of gastrointestinal endoscopy.The study presented a 66-year-old male patient who developed cerebral arterial gas embolism shortly after therapeutic endoscopic retrograde cholangiopancreatography (ercp) for acute biliary pancreatitis, which is the first case reported in hong kong according to latest literature search.Some risk factors of iatrogenic air embolism in this patient include cholangitis with intraductal stones, sphincterotomy and bleeding at papillotomy site which required haemostasis with balloon tamponade.Early diagnosis and timely treatment with hyperbaric oxygen therapy resulted in full neurological recovery of the patient.Type of adverse events/number of patients post-endoscopic retrograde cholangiopancreatography cerebral arterial gas embolism - (1)  .
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Additional information from the author: the author stated the olympus device did not cause or contribute to the adverse event and it's due to the procedure of papillotomy.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer's investigation.New information added to the following fields: h6, h10.Although the author stated the olympus device did not cause or contribute to the adverse event, the adverse event will remain a serious injury.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Common Device Name: SINGLE USE 2-LUMEN 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: 14192726
• Report Number: 8010047-2022-06975
• Device Sequence Number: 4406866
• Product Code: KNS
• UDI-Device Identifier: 04953170183973
• UDI-Public: 04953170183973
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

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-V411M-0320
• Device Lot Number: UNKNOWN(LITERATURE)
• 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: 03/27/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 06/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Male