MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number TJF-260V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pancreatitis (4481)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

[auto-translated] olympus medical systems corp.(omsc) received a literature titled "radiation-free digital cholangioscopy-guided laser lithotripsy for large common bile duct stones: feasibility and technical notes".The study reported the experience of non-radiation endoscopic retrograde cholangiopancreatography (ercp) for large cbd stones using digital cholangioscopy-guided laser lithotripsy.Biliary access was achieved in all patients using standard guidewire-assisted cannulation, double-guidewire technique, and transpancreatic precut in twelve, two, and two patients, respectively.Balloons of 10 mm, 8 mm, and 6 mm in diameter were applied for epbd in 8, 2, and 6 patients, respectively.Complete stone removal in one session was achieved in all patients.One round of laser lithotripsy was needed for stone = 25 mm, and three-to-five rounds were needed for stones > 25 mm or multiple stones.One or two clips were used for endoscopic clipping.The time lengths of biliary access, digital cholangioscopy-assisted laser lithotripsy and stone extraction, and whole procedure were 3.5 ± 3.2 (0.5¿12) minutes, 52.5 ± 30.6 (45¿97) minutes, and 76 ± 23.3 (58¿106) minutes, respectively.Asymptomatic hyperleukocytose, hyperamylasemia, and mild pancreatitis were present in 1, 2, and 1 patient(s), respectively.No other complications occurred.No cholangitis or recurrent cbd stones were observed.Non-radiation digital cholangioscopy-guided laser lithotripsy is technically feasible and can be safely performed for endoscopic management of large cbd stones.Type of adverse events/number of patients.Asymptomatic hyperleukocytose - 1 patient.Hyperamylasemia - 2 patients.Mild post-ercp pancreatitis - 1 patient.Spontaneous biliary stent dislodgement - 4 patients.Since the literature described "tjf-260" but it was not registered, we selected "tjf-260v.".

Manufacturer Narrative

This supplemental report is being submitted for additional information from the customer.D4: serial no.Is (b)(6).

Event Description

Additional information received from the author: in the medical opinion of the author, the olympus devices did not cause or contribute to the adverse events described in this literature.The author stated there was no olympus device malfunction.

Manufacturer Narrative

This report is being supplemented to provide a correction and additional information based on the legal manufacturer's final investigation.The serial number of the device was (b)(6), therefore the device history record was reviewed for both devices.All records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.H4: manufacturing date of the devices was as below: tjf-260v, sn#(b)(6): 27may2019, tjf-260v, sn#(b)(6): 26dec2017.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• 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: 14748533
• MDR Text Key: 294418737
• Report Number: 8010047-2022-10379
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2022

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
• Device Operator: Health Professional
• Device Model Number: TJF-260V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 06/07/2022; 06/29/2022
• Supplement Dates FDA Received: 06/28/2022; 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other