MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III COLONOVIDEOSCOPE

Model Number PCF-HQ190L

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2023

Event Type  malfunction  

Manufacturer Narrative

The suspect device has not been returned to olympus.Additional information has been requested but no information could be provided.The investigation is ongoing.A supplemental report will be submitted upon complication or if additional information is received.

Event Description

Olympus reviewed the following literature titled "first-in-human side-to-side magnetic compression duodeno-ileostomy with the magnet anastomosis system".Purposes: classical gastrointestinal anastomoses are formed with sutures and/or metal staples, resulting in significant bleeding and leak rates.This study evaluated the feasibility and safety of the novel magnet anastomosis system (ms) to create a side-to-side duodeno-ileal (di) diversion for weight loss and type 2 diabetes (t2d) resolution.Materials and methods: patients with severe obesity (body mass index (bmi)=35 kg/m2 with/without t2d (hba1c=6.5%)) underwent the study procedure, a side-to-side ms di diversion, with a standard sleeve gastrectomy (sg).A linear magnet was delivered by flexible endoscopy to a point 250 cm proximal to the ileocecal valve; a second magnet was positioned in the first part of the duodenum; the bowel segments containing magnets were apposed, initiating gradual anastomosis formation.Laparoscopic assistance was used to obtain bowel measurements, obviate tissue interposition, and close mesenteric defects.Results: between november 22 and 26, 2021, 5 female patients (mean weight 117.6±7.1 kg, bmi (kg/m2) 44.4±2.2) underwent side-to-side ms di+sg.All magnets were successfully placed, expelled without re-intervention, and formed patent durable anastomoses.Total weight loss at 12 months was 34.0±1.4% (sem); excess weight loss, 80.2±6.6%; and bmi reduction, 15.1.Mean hba1c (%) dropped from 6.8±0.8 to 4.8±0.2; and glucose (mg/dl), from 134.3±17.9 to 87.3±6.3 (mean reduction, 47.0 mg/dl).There was no anastomotic bleeding, leakage, obstruction, or infection and no mortality.During the first 30 days, there were no device-related aes or saes.Three patients had mild pain in their postoperative abdominal wounds (cdc grade i); these were treated with an intramuscular analgesic injection and resolved without sequelae.One patient had a mild mucosal tear of the upper esophagus due to endoscopic overtube insertion (cdc grade i; use of an overtube was subsequently removed from the procedure); the event resolved on the same day without sequalae.Another patient sustained an intra-abdominal hematoma adjacent to the sg staple line in the upper left quadrant diagnosed by ct scan (cdc grade ii); she was observed for 24 h due to poorly controlled hypertension and required no transfusions.The hematoma was on the side opposite from the magnets and adjacent to the sleeve staple line.A final patient had a serosal tear of the ileum due to a pulling motion by laparoscopic forceps during the procedure (cdc grade iii); this was immediately sutured as a precaution and resolved on the same day.Conclusions: creation of a side-to-side magnetic compression anastomosis to achieve duodeno-ileostomy diversion in adults with severe obesity was feasible and safe, achieved excellent weight loss, and resolved type 2 diabetes at 1-year follow-up.Type of adverse events/number of patients: event 1 :mucosal tear of upper esophagus due to overtube insertion - 1 patient.Event 2: serosal tear of ileum (5 mm) due to laparoscopic forceps - 1 patient.Event 3: mild abdominal pain from procedure wounds - 3 patients.Event 4: intra-abdominal hematoma at sleeve staple line, upper left quadrant - 1 patient.Event 5: vitamin b12 deficiency - 5 patients.Event 6: vitamin d deficiency - 1 patient.Event 7: covid-19 positive - 3 patients.Event 8: constipation - 1 patient.This literature article requires 2 reports.The related patient identifiers are as follows: 1) (b)(6): the reportable device malfunction for evis exera iii colonovideoscope; pcf-hq190l is captured under the (b)(6) for "insertion tube braids or bending mesh (sharp edges) protrude outward".2) (b)(6): the adverse and serious adverse events for evis exera iii colonovideoscope; pcf-hq190l have been captured under the (b)(6).This medwatch report is for patient identifier (b)(6) for model: pcf-hq190l.

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 cause of the event could not identified, for neither an abnormality nor issue of the subject device was reported.Therefore, the root cause cannot be determined.This supplemental report includes new information received.B5 update accordingly.Olympus will continue to monitor field performance for this device.

Event Description

It was confirmed that there was no olympus device malfunction in any of the procedures described in the literature article.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• 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: 17461492
• MDR Text Key: 321524832
• Report Number: 9610595-2023-11181
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170416118
• UDI-Public: 04953170416118
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K192793
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-HQ190L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2023
• 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