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

Model Number SIF-Q260

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 06/12/2023

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "balloon-assisted enteroscopy-based endoscopic stricturotomy for deep small bowel strictures from crohn's disease: first cohort study of a novel approach".Literature summary background: there is little data on the role of endoscopic stricturotomy (es) in treating deep small bowel strictures.We aimed to investigate the efficacy and safety of balloon-assisted enteroscopy-based es (bae- based es) for deep small bowel strictures associated with crohn¿s disease (cd).Methods: this multicentre retrospective cohort study included consecutive patients with cd-associated deep small bowel strictures treated with bae-based es between 2017 and 2023.The outcomes included technical success, clinical improvement, surgery-free rate, reintervention-free rate, and adverse events.Results: twenty-eight patients with cd underwent 58 bae-based es procedures for non-passable deep small bowel strictures, with a median follow-up time of 519.5 days (interquartile range, 306¿728 days).Fifty-six (96.0%) procedures were technically successful in 26 (92.9%) patients.Twenty patients (71.4%) showed clinical improvement at week 8.The cumulative surgery-free rate at 1 year was 74.8% (95% confidence interval [ci], 60.3¿92.9%).A higher body mass index was associated with a decreased need for surgery (hazard ratio = 0.084, 95% ci, 0.016¿0.45, p = 0.0036).Postprocedural adverse events (bleeding and perforation) requiring reintervention occurred in 3.4% of the procedures.Conclusions: the novel bae-based es provides high technical success, favorable efficacy, and safety in cd- associated deep small bowel strictures, which may provide an alternative for endoscopic balloon dilation and surgery.Type of adverse events/number of patients: 1) event 1: bleeding/number of patients-3.2) event 2 : perforation/number of patients-2.One case of bleeding occurred during the procedure and was successfully controlled with endoclips and in other two cases bleeding occurred within 3 days after the procedure and were treated by emergency enteroscopy or surgery.A total of two cases of perforation occurred.In one patient, perforation occurred during the procedure and was immediately treated with endoclips.One patient reported moderate to severe abdominal pain in the evening of the procedure, and a ct scan showed a suspected perforation.However, the pain resolved spontaneously without reintervention.This literature article requires 4 reports.The related patient identifiers are as follows: 1.(b)(6); evis lucera small intestinal videoscope; sif-q260 2.(b)(6); single use electrosurgical knife ; kd-620ur 3.(b)(6); single use electrosurgical knife kd-612; kd-612u 4.(b)(6); single use electrosurgical hemostatic forceps; fd-411ur the 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

E1 : establishment name: air force general hospital, the fourth military medical university.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.

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.In addition, from a clinical/medical evaluation and risk assessment, it is possible that the reported event is an accident, or a complication associated with a procedure using the subject device.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18123799
• MDR Text Key: 328005554
• Report Number: 9610595-2023-17070
• Device Sequence Number: 1
• Product Code: FDA
• 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,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SIF-Q260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2023
• 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
• Treatment: ELECTROSURGICAL HEMOSTATIC FORCEPS, FD-411UR; KD-612U, SINGLE USE ELECTROSURGICAL KNIFE; SINGLE USE ELECTROSURGICAL KNIFE, KD-620UR
• Patient Outcome(s): Required Intervention