MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE SMALL INTESTINAL VIDEOSCOPE; SMALL INTESTINAL VIDEOSCOPE

Model Number SIF-H290S

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

Patient Problem Perforation (2001)

Event Date 01/26/2024

Event Type  Injury  

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.

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 15,748 biliary and pancreatic endoscopic procedures (ercp8432 and eus7316 cases) performed from january 2009 to september 2023, 11 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 5 males and 6 females.The incidence rate was 0.071% in 6 ercp cases (including 1 bea-ercp case), 0.068% in 5 eus cases, and the scope used was gf-uct260 in 4 cases, gf-um2000 in 1 case, jf-260v in 4 cases, tjf-q290v in 1 case, and sif-h290s in 1 case.In 9 of the 11 cases, the examination was performed by a physician with less than 5 years of endoscopic experience.The perforation sites were 3 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).

• Brand Name: EVIS LUCERA ELITE SMALL INTESTINAL VIDEOSCOPE
• Type of Device: SMALL INTESTINAL VIDEOSCOPE
• 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: 18899741
• MDR Text Key: 337634914
• Report Number: 9610595-2024-05393
• Device Sequence Number: 1
• Product Code: FDA
• 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: SIF-H290S
• 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; DUODENOVIDEOSCOPE, TJF-Q290V, SN UNK; GASTROVIDEOSCOPE, GF-UCT260, SN UNK; ULTRASONIC GASTROVIDEOSCOPE, GF-UM2000, SN UNK
• Patient Outcome(s): Required Intervention; Hospitalization