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 Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 11/09/2021

Event Type  Injury  

Manufacturer Narrative

This device is not available to return for evaluation.Attached is a copy of the literature.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

Olympus medical systems corp.(omsc) received a literature titled, "retrospective analysis of the outcomes of endoscopic submucosal dissection for the diagnosis and treatment of subepithelial lesions in a center with high expertise." this study aimed to assess the diagnostic and therapeutic utility of endoscopic submucosal dissection (esd) for the management of subepithelial lesions (sels) in a tertiary esd referral center.A total of 634 esds were reviewed, 55 (9%) were performed in sels, (6 in the esophagus, 34 in the stomach, and 15 in the rectum).Neuroendocrine tumors, gastrointestinal stromal tumors, and granular cell tumors accounted for 38% of the procedures, with a 100% rate of en bloc resection and 65% of r0 resection; the main criterion for non-curative resection was a deep positive margin, and none of the patients treated with complementary surgery had lesions on the gastrointestinal wall.The reasons for esd in these lesions were the uncertainty of the diagnosis after eus evaluation and, in 1 case, also the lesion growth between 2 eus (anectopic pancreas).Esd can be an effective treatment for sels, even with lower curative rates comparing to procedures on epithelial lesions.Type of adverse events/number of patients perforation (granular cell tumor in the esophagus, closure with endoscopic clipping) (1 patient) bleeding after discharge needing readmission (1 patient) needed hemostasis with clips during esd (1 patients) delayed bleeding (2 patients) (b)(6) - dual-knives (kd-650l (single use electrosurgical knife kd-650)) (b)(6) - insulated tip (it)-2 (kd-611l (single use electrosurgical knife)) (b)(6) - it-nano knives (kd-612l (single use electrosurgical knife kd-612)) (b)(6) - coagrasper (fd-410lr (single use electrosurgical hemostatic forceps)) (b)(6) - high definition endoscopes (gif-h180 (evis exera ii gastrointestinal videoscope)) (b)(6) - high definition endoscopes (gif-h190 (evis exera iii gastrointestinal videoscope)) this report is for (b)(6).

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the author and to provide additional information based on the legal manufacturer's final investigation.New information added to the following fields: b5 and h6.The device history record was unable to be reviewed for this device as no serial number was provided.Based on the results of the investigation, it is likely the reported event is an accident, or a complication associated with a surgical procedure using the subject device.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.

Event Description

Olympus further received information from the author/physician that the events describe in the study are considered normal for the technique used.Furthermore, the physician confirmed that no olympus device contribute to the events described in the study.

• 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: 16892625
• MDR Text Key: 314801105
• Report Number: 9610595-2023-07227
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170339776
• UDI-Public: 04953170339776
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

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-H180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 05/18/2023
• Supplement Dates FDA Received: 06/13/2023
• 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
• Treatment: KD-650L, KD-611L, KD-612L, FD-410LR, GIF-H190.
• Patient Outcome(s): Hospitalization; Required Intervention