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

Model Number TJF-Q290V

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

Patient Problem Perforation (2001)

Event Date 01/26/2024

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "a study on scope perforation in biliary pancreatic endoscopes".Literature summary [background] ercp and eus-related procedures are essential for the diagnosis and treatment of biliary and pancreatic diseases.Incidental incidents associated with the procedure occur with a certain frequency, but perforation of the gastrointestinal tract with a scope is a serious occurrence and requires prompt response, including surgery.At our hospital, we have also experienced scope perforation during ercp and eus, and we examined troubleshooting.[targets and methods] of the (b)(4) biliary and pancreatic endoscopic procedures ((b)(4) cases) performed from (b)(6) 2009 to (b)(6) 2023, (b)(4) patients with scope perforation were subjected to retrospective examination of the clinical background, response at the time of perforation, and treatment course.[result] the median age of the patients was 76 years (66¿87 years) and the sex was (b)(4) males and (b)(4) females.The incidence rate was (b)(4) in 6 ercp cases (including 1 bea-ercp case), (b)(4) in (b)(4) eus cases, and the scope used was gf-uct260 in (b)(4) cases, gf-um2000 in (b)(4) case, jf-260v in (b)(4) cases, tjf-q290v in (b)(4) case, and sif-h290s in (b)(4) case.In (b)(4), the examination was performed by a physician with less than 5 years of endoscopic experience.The perforation sites were (b)(4) cases of the esophagus (2 cases at the entrance, 1 case in the middle thoracic esophagus), 7 cases in the duodenum (1 case in the ball, 2 cases in the superior duodenal angle, and 4 cases in the descending leg), and 1 case in the jejunum.All of the cases of esophageal perforation were perforated at the time of insertion of the scope, and emergency surgery was performed in two cases, and conservative treatment with fasting and antibiotics was performed in one case due to inoperative intolerance.The median length of antibiotic treatment was 30 days (13-35 days) and the median length of hospital stay was 38 days (35-48 days).All of the duodenal perforation cases were perforated during stretching to the descending leg, and emergency surgery was performed in 5 cases, and endoscopic stitching (1 clip stitch and 1 otsc) was performed in 2 cases.The median number of days of antibiotic administration was 8 days (5-23 days) and the median length of hospital stay was 16 days (9-47 days).In the case of jejunal perforation, perforation occurred at the time of scope insertion, and endoscopic stitching (combination of clip and otsc) was performed.The number of days of antibiotics was 9 days and the number of days of hospitalization was 19 days.No deaths were found due to scope perforation.[conclusion] scope perforation in biliary pancreatic endoscopy requires long-term hospitalization and administration of antibiotics.When scope perforation occurs, endoscopic stitching should be considered, and if it is difficult, surgery should be considered promptly.Type of adverse events/number of patients perforation (11).

Manufacturer Narrative

The report is related to the following linked patient identifiers.(b)(6).Once the investigation has been completed, a supplemental report will be submitted with the device evaluation results.

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 b5 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

Event Description

It was confirmed by the author that an olympus device malfunction did not occur during any of the procedures described in the article.

• Brand Name: EVIS LUCERA ELITE 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18899703
• MDR Text Key: 337621854
• Report Number: 9610595-2024-05392
• 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
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-Q290V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• 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: DUODENOSCOPE, JF-260V, SN-UNK; GASTROVIDEOSCOPE, GF-UCT260, SN-UNK; SINGLE-BALLOON ENTEROSCOPE, SIF-H290S , SN-UNK; ULTRASONIC GASTROVIDEOSCOPE, GF-UM2000, SN-UNK
• Patient Outcome(s): Required Intervention; Hospitalization