MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA DUODENOVIDEOSCOPE

Model Number TJF-260V

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

Patient Problem Pancreatitis (4481)

Event Date 11/15/2022

Event Type  Injury  

Event Description

Olympus received the following literature titled "pancreatic duct lavage cytology combined with a cell-block method for patients with possible pancreatic ductal adenocarcinomas, including pancreatic carcinoma in situ." background/aims: this study aimed to clarify the efficacy and safety of pancreatic duct lavage cytology combined with a cell-block method (plc-cb) for possible pancreatic ductal adenocarcinomas (pdacs).Methods: this study included 41 patients with suspected pdacs who underwent plc-cb mainly because they were unfit for undergoing endoscopic ultrasonography-guided fine needle aspiration.A 6-fr double lumen catheter was mainly used to perform plc-cb.Final diagnoses were obtained from the findings of resected specimens or clinical outcomes during surveillance after plc-cb.Results: histocytological evaluations using plc-cb were performed in 87.8% (36/41) of the patients.For 31 of the 36 patients, final diagnoses (invasive pdac, 12; pancreatic carcinoma in situ, 5; benignancy, 14) were made, and the remaining five patients were excluded due to lack of surveillance periods after plc-cb.For 31 patients, the sensitivity, specificity, and accuracy of plc-cb for detecting malignancy were 94.1%, 100%, and 96.8%, respectively.In addition, they were 87.5%, 100%, and 94.1%, respectively, in 17 patients without pancreatic masses detectable using endoscopic ultrasonography.Four patients developed postprocedural pancreatitis, which improved with conservative therapy.Conclusions: plc-cb has an excellent ability to detect malignancies in patients with possible pdacs, including pancreatic carcinoma in situ.Post-endoscopic retrograde cholangiopancreatography pancreatitis (pep) developed in four patients (9.8%; moderate severity, 3; mild severity, 1).Of the four patients with pep, one patient with moderate pep did not undergo pancreatic stent replacement and administration of nsaids, whereas the remaining three underwent both prophylactic treatments.The pep in these patients improved with conservative treatment.No other adverse events associated with ercp were observed in any of the patients.Related patient identifiers: case 15 (66, male): (b)(6) - evis lucera duodenovideoscope (tjf-260v) (b)(6) - cannula (pr-104q-1) case 16 (61, female): (b)(6) - evis lucera duodenovideoscope (tjf-260v) (b)(6) - cannula (pr-104q-1) case 16 case 20 (79, female): (b)(6) - evis lucera duodenovideoscope (tjf-260v) (b)(6) - cannula (pr-104q-1) case 41 (75, female) (b)(6) - evis lucera duodenovideoscope (tjf-260v) (b)(6) - cannula (pr-104q-1) this medwatch is for patient identifier (b)(6).

Manufacturer Narrative

The device was not returned to olympus for evaluation.The literature article is attached for additional information.Doi.Org/10.5946/ce.2022.021 provided for additional information.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18649750
• MDR Text Key: 334635075
• Report Number: 9610595-2024-02515
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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
• Date Manufacturer Received: 02/26/2024
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: CANNULA (PR-104Q-1)
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female