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

Model Number GIF-Q260

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

Patient Problem Perforation (2001)

Event Date 10/20/2023

Event Type  Injury  

Event Description

Olympus reviewed the following literature titled,"long-term outcomes of endoscopic resection for duodenal neuroendocrine tumors." duodenal neuroendocrine tumors (d-nets) = 10 mm in size, confined to the submucosal layer, without lymph node or distant metastasis, can be treated safely and effectively by endoscopic management.However, most results are based on limited data and short follow-up outcomes.Herein, we aimed to evaluate the short-term and long-term outcomes of endoscopic resection for d-nets.We retrospectively analyzed 63 patients with 68 d-nets who had undergone endoscopic resection at two hospitals between january 2009 and december 2021.En-bloc resection, endoscopically complete resection, and histopathologically complete resection rates were evaluated as short-term outcomes.Furthermore, long-term outcomes were analyzed in 46 patients with 50 d-nets with a follow-up period of > 1 year.The overall en-bloc, endoscopically complete, and histopathologically complete resection rates were 92.6% (63/68), 100% (68/68), and 69.1% (47/68), respectively.Tumor size (> 5 mm) was the only predictive factor for histopathologically incomplete resection (p = 0.015).The procedure related bleeding and perforation rates were 0% and 5.9%, respectively.No recurrences were observed in patients with histopathologically complete resection and those with histopathologically incomplete resection at a median follow-up period of 48 months (range 12¿132 months).Endoscopic resection for d-nets = 10 mm in size, limited to the submucosal layer, and without lymph node or distant metastasis provides favorable long-term outcomes when endoscopically complete resection is achieved.Type of adverse events/number of patients: perforation (4).Intraprocedural perforation was noted in 4 cases.All cases were successfully closed using hemoclips.There is no report of any olympus device malfunction in any procedure described in the literature.Additional information from the author that indicated that it is unknown if the subject device caused or contributed to any of the patient adverse events described in the literature.

Manufacturer Narrative

E1 establishment name: (b)(6).Since the literature described "conventional single-channel endoscope (gif-q260, gif-h260)", olympus selected "gif-q260" as a representative product.The literature article is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information provided through follow up.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.Olympus will continue to monitor field performance for this device.

Event Description

The author comments that it is unknown if any olympus device cause or contribute to any of the patient adverse events described in this literature or if any olympus device malfunction during any procedure described in this literature.

• Brand Name: EVIS LUCERA 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: 18150313
• MDR Text Key: 328300842
• Report Number: 9610595-2023-17460
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2023

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-Q260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 11/21/2023
• Supplement Dates FDA Received: 12/01/2023
• 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