MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-Q260J

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

Patient Problem Insufficient Information (4580)

Event Date 01/01/2019

Event Type  Death  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

In the literature titled ¿efficacy and safety of endoscopic resection for gastric tube cancer after surgical resection of esophageal squamous cell carcinoma,¿ patients experienced adverse events after procedures using olympus devices.Case with patient identifier (b)(6) reports the gif-q260j used in procedures with adverse events.Case with patient identifier (b)(6) reports the kd-611l used in procedures with adverse events.Case with patient identifier (b)(6) reports the kd-650l used in procedures with adverse events.Case with patient identifier (b)(6) reports the gif-q260j used in procedures with patient deaths during study follow-up period.Case with patient identifier (b)(6) reports the kd-611l used in patient procedures with patient deaths during study follow-up period.Case with patient identifier (b)(6) reports the kd-650l used in patient procedures with patient deaths during study follow-up period.Study background/aim: gastric tube cancers (gtcs) are found frequently, even as the surgical outcomes of esophageal cancer improve.Diagnosing and treating early gastric tube cancer endoscopically has therefore become very important.This study aimed to evaluate the clinical characteristics and outcomes of endoscopic resection for gtc.Methods: the study analyzed 29 patients (33 lesions) with metachronous gtc who underwent endoscopic resection from april 2005 to august 2016 and evaluated their clinical characteristics and the short-term outcomes of endoscopic resection.Results: all of the cases were identified by periodic examinations.The lesions were found a median of 6.5 years after surgery (range 9 months¿19 years), with six lesions found more than 10 years later.Among the total of 33 lesions, 28 resulted in curative resections (85%), and five were non-curative resections because of lymphovascular invasion, submucosal deep invasion, histological type, and size.None had received additional treatment or had a local recurrence thus far.Regarding the complications, delayed perforation occurred in a case (3%) and precordial skin burn occurred in four cases (12%).Conclusion the safety and efficacy of endoscopic resection for gastric tube cancer were evaluated.Additionally, it is important to continue annual endoscopy even 5 years or more after esophageal surgery conclusion: endoscopic resection for gct has safety and efficacy.Additionally, it is important to continue peri odic endoscopy even 5 years or more after esophagectomy and to detect lesions as early as possible.Early detection makes it possible to select a less invasive endoscopic treatment and achieve curative resection.There were 28 curative resections (85%) and five non-curative resections (15%).No patients underwent additional treatment after full consultation.The median period of follow-up was 1.8 years (range 5 months¿10.6 years).Eight patients have died thus far, including four non-curative resection patients (table 4).Only one patient who underwent curative resection had metachronous gtc with carcinomatous pleurisy at 1 year after esd.He could not continue his hospital visits because of his own convenience, which was treatment of alcohol abuse after esd.He visited the hospital at 1 year after esd.Endoscopic examination revealed advanced type 4 gtc, and ct showed pleural and cardiac effusion.Signet-ring cell carcinoma was detected from his pericardial effusion.He received systemic chemotherapy but died after 3 months.No other causes of death were related to gtc: cerebral infarction, bony metastasis due to esophageal cancer recurrence, interstitial pneumonia, and hypopharyngeal cancer.The 2-year and 5-year overall survival rate for all patients was 73.3% and 64.1% (fig.4).Five of the dead cases developed second primary cancers in other regions, such as the lung and pharynx.In addition, three out of 29 gtc patients had esophageal cancer recurrence.Only one patient died, and two patients are in treatment.There is no report of olympus device malfunction described in this study.

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 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.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14345308
• MDR Text Key: 291282397
• Report Number: 8010047-2022-07944
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

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-Q260J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 06/02/2022
• 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; Death; Required Intervention