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

Model Number GIF-1TH190

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

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

Event Date 03/14/2023

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled "clinical outcomes of the endoscopic step-up approach with or without radiology-guided percutaneous drainage for symptomatic walled-off pancreatic necrosis." abstract: background and objectives: symptomatic walled-off pancreatic necrosis is a serious local complication of acute necrotizing pancreatitis.The endoscopic step-up approach is the standard treatment for symptomatic walled-off pancreatic necrosis; however, adjunctive radiologic percutaneous drainage for this condition is controversial.This study compared the clinical and radiologic resolution of walled-off pancreatic necrosis achieved with the endoscopic step-up approach with or without radiology-guided percutaneous drainage.Material and methods: this retrospective, single-center cohort study enrolled patients with symptomatic walled-off pancreatic necrosis who underwent endoscopic transmural drainage (etd) followed by directed endoscopic necrosectomy (den) with or without radiology-guided drainage.A total of 34 patients (endoscopic approach, n = 22; combined modality approach, n = 12) underwent the endoscopic step-up approach (etd followed by den).Baseline characteristics, clinical success, and resolution of necrosis were compared between groups.Results: all patients achieved symptom resolution from walled-off pancreatic necrosis.The mean patient age was 58.4 years, and 21 (61.8%) were men.Following treatment with the endoscopic approach and combined modality approach, clinical success was achieved in 90.9% of patients within 11.5 days, and 66.7% of patients within 16.5 days, respectively.Both length of hospital stay (55 days vs.71 days; p = 0.071) and time to complete radiologic resolution were shorter (93 days vs.124 days; p = 0.23) in the endoscopic approach group.Conclusion: both the endoscopic step-up approach and the cmd approach resulted in a favorably high clinical resolution rates in patients with symptomatic won.However, clinical success rates seemed to be higher, and the length of hospital stay tended to be shorter in the endoscopic approach than in the cmd approach, as well as the significantly shorter necrosectomy time in each procedure was observed.Of note, these findings might be from some inherited differences in baseline characteristics of the patients between the two groups, and a randomized controlled trial with a larger sample size to verify these results is warranted.Type of adverse events/number of patients: bleeding, 15 patients; perforation, 1 patient.This literature article requires 2 reports.The related patient identifiers are as follows: -(b)(6) :gf-uct180; -(b)(6) :gif-1th190.This 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

Since the literature described "gastroscope (evis exera iii, gif-1th190)", olympus selected "gif-1th190" as a representative product.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article doi: https://doi.Org/10.3390/medicina59030569.Provided 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.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 16745834
• MDR Text Key: 313356424
• Report Number: 9610595-2023-06169
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170343360
• UDI-Public: 04953170343360
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K112680
• 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: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-1TH190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 05/10/2023
• Supplement Dates FDA Received: 05/18/2023
• 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): Required Intervention