MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H180

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

Patient Problems Perforation (2001); Pneumothorax (2012)

Event Type  Injury  

Event Description

It is reported in the literature titled ¿per oral endoscopic myotomy (poem) for pediatric achalasia: institutional experience and outcomes,¿ patients experienced adverse events during or after procedures using an evis exera ii gastrointestinal videoscope.Background: the surgical treatment of achalasia by both laparoscopic and endoscopic approaches has been recognized as the definitive management in children.Despite reported low volumes in many centers, there has been an increasing worldwide experience with endoscopic approaches to pediatric achalasia.The aim of this study is to report our institutional experience with per oral endoscopic myotomy (poem) as first-line or revisional therapy for achalasia.Methods: an irb approved retrospective review of all patients who underwent operative procedures for achalasia, specifically with the poem technique, from july 2015 to september 2021.Data including demographics, intra-operative details, pre and post operative eckhardt scores, complications, outcomes, and follow-up were obtained.Results: during the study period, a total of 43 children underwent 46 operations for achalasia including poem and laparoscopic heller myotomy (lhm).Operations included 37 poems (33 primary poems; 3 poems after failed lhm; and 1 poem after failed poem).Additionally, 9 lhm operations including, 4 primary lhm; 3 attempted poems converted to lhm; 1 attempted poem after failed lhm converted to redo lhm; and 1 lhm after failed poem.In the poem group (n = 37), based on the high-resolution esophageal manometry findings chicago classification types at diagnosis were as follows: 9 patients were type i (24.3%); 25 patients were type ii (67.6%); 2 patients were type iii (5.9%) and 1 patient was unknown type (2.7%).Sixteen children (43.2%) had prior endoscopic treatment of achalasia prior to poem [pneumatic balloon dilatation (pbd), and/or botox injection (bti)],), while prior operative intervention occurred in 4 patients (10.8%), 3 lhm and 1 poem.Age at operation was 2¿18 years (mean ± sd age: 11.6 ± 4.5 years).Weight at operation 11.8¿100.7 kg (mean ± sd kg; 39 ± 19.9 kg).Range of baseline eckhardt score was 4¿10 (mean ± sd: 6.73 ± 1.5).Operative time was 64¿359 min (mean ± sd minutes: 138.1 ± 62.2 min).Intraoperative complications occurred in 16 patients (43.2%) but did not require reoperation during index admission including: 4 mucosotomy (11.8%); 9 pneumothoraces (24.3%); 2 pneumomediastinum (5.4%); 10 pneumoperitoneum (27%); 0 sub-mucosal tunnel bleeding (0%); 0 open conversion/death (0%).Post operative complications included: 5 recurrent dysphagia (13.5%); 0 esophageal leak (0%); 3 gerd (8.1%); 1 failed poem (2.7%).Median length of stay was 2 days (mean ± sd days: 2.4 ± 0.9 day).Follow-up ranged from 1 to 74 months (median 15 months), mean follow-up 22.6 months ± 20 months.Post poem eckhardt score was 0.6 ± 0.9.Five patients required a single pbd post poem (13.5%) and 1 patient required a repeat myotomy (lhm) after poem (2.7%) for a 16.2% reintervention rate.Subsequent normalization of eckhardt scores (= 3) and symptomatic relief was achieved in all patients (100%).Conclusions: poem as first-line therapy for pediatric achalasia, or as a secondary procedure after failed prior myotomy or poem, in our experience is safe and effective.We have shown equivalent results to our own prior experience with lhm.Long-term follow-up will be performed to monitor for recurrent symptoms, adequate physical growth, and general development.There is no report of any olympus device malfunction in any procedure described in this literature.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# (b)(4).

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 g2.Information added to g2 that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

Event Description

Attempts to retrieve additional information from the author are in progress.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL 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: 15978092
• MDR Text Key: 305490030
• Report Number: 9610595-2022-05434
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170339776
• UDI-Public: 04953170339776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-H180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2023
• 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): Other; Required Intervention