MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT260

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

Patient Problem Pancreatitis (4481)

Event Date 11/19/2022

Event Type  Injury  

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 Description

Olympus reviewed the following literature titled "efficacy and safety of one-stage eus-fna and bile duct metal stent placement for pancreatic cancer with obstructive jaundice".Eus-fna is a useful and safe procedure for diagnosing biliary pancreatic disease.Biliary drainage by ercp is performed for treatment purposes in patients with obstructive jaundice.This time, we investigated a case in which ercp was performed following eus-fna, and placement of a bile duct metal stent was attempted in the same session.Methods from october 2019 to july 2022, the subjects were 15 patients with suspected obstructive jaundice due to pancreatic cancer based on blood and imaging tests at our hospital (age 46-86 years (average 73 years), 13 males, 2 females).Gf-uct260 and tjf-q290v scopes were used.Pentazocine was used as an analgesic, and midazolam was used as a sedative.After specimen collection by fna, rapid cytology was performed, followed by biliary metal stent placement by ercp.The items to be examined were (1) disease breakdown, (2) eus-fna procedure details, (3) ercp procedure details, (4) complications, (5) implementation time, (6) quantity used of analgesics/sedatives.Results (1) there were 13 cases of pancreatic cancer (11 cases of head, 2 cases of body) and 2 cases of autoimmune pancreatitis.(2)puncture was performed in 14 cases (1 case was skipped due to involvement of ipmc), the number of punctures was 1-5 times (average 2.4 times), and the puncture route was transgastric in 2 cases and transduodenal in 12 cases.A 22g needle was used in 12 cases and a 25 needle in 2 cases.Rapid cytological diagnosis was class iv or better in 12 cases of pancreatic cancer, and class ll in 2 cases of autoimmune pancreatitis.(3) bile duct intubation was successful in all cases.Biliary metal stents were placed in 12 patients, and nasobiliary drainage tubes were placed in 3 patients.(4) mild post-ercp pancreatitis developed in 2 of the 15 patients, but was relieved by conservative treatment.No eus-fna complications were observed.(5) eus-fna took 20-70 minutes (average 43 minutes), ercp took 10-50 minutes (average 22 minutes), and total administration time was 40-100 minutes (average 74 minutes).(6) pentazine doses ranged from 15 to 22.5 mg (mean 17 mg), and midazolam doses ranged from 3 to 9 mg (5.7 mg).Conclusion one-stage eus-fna and biliary metal stent placement can be safely performed without lowering the procedural success rate.Type of adverse events/number of patients.Mild post-ercp pancreatitis n=2 this literature article requires 2 reports.The related patient identifiers are as follows: (b)(6); (gf-uct260) (b)(6); (tjf-q290v).This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.

Manufacturer Narrative

This supplemental report is being submitted to provided additional information from the author (see b5).

Event Description

In the medical opinion of the author, the olympus device did not cause malfunction nor the adverse events reported.

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 event 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.This supplemental report includes a correction to e4 to provide information that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16106338
• MDR Text Key: 306777343
• Report Number: 3002808148-2023-00127
• Device Sequence Number: 1
• Product Code: ODG
• 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,Followup
• Report Date: 02/24/2023

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: GF-UCT260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 01/13/2023; 02/14/2023
• Supplement Dates FDA Received: 01/13/2023; 02/24/2023
• 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
• Patient Outcome(s): Required Intervention