MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE; SMALL INTESTINAL VIDEOSCOPE

Model Number SIF-Q180

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/10/2020

Event Type  Injury  

Event Description

Olympus medical systems corp (omsc) received a literature titled "does urgent balloon-assisted enteroscopy impact rebleeding and short-term mortality in overt obscure gastrointestinal bleeding?."   background and aims: the diagnostic yield (dy) and therapeutic yield (ty) of balloon-assisted enteroscopy (bae) in overt obscure gastrointestinal bleeding (ogib) is higher in the first 72 h.This study aimed to evaluate if this higher dy and ty after urgent bae impacted the rebleeding rate, time to rebleed and short-term mortality.Methods: retrospective cohort-study, which consecutively included all patients submitted to bae for overt ogib, between 2010 and 2019.Patients were distributed in 2 groups: (1) urgent bae; (2) nonurgent bae.Rebleeding was defined as an hb drop >2 g/dl, need for transfusional support or presence of melena/hematochezia.Results: fifty-four patients were included, of which 17 (31.5%) were submitted to bae in the first 72 h.Dy and ty of urgent bae (dy 88.2%; n ¼ 15; ty 94.1%; n ¼ 16) was higher compared to non-urgent bae (dy 59.5%; n ¼ 22; ty 45.9%; n ¼ 17) (dy p ¼.03) (ty p ¼.001).The rebleeding rate at 1, 2, and 5 years was 32.0%, 34.0%and 37.0%, respectively.Rebleeding was lower after urgent bae (17.6%; n ¼ 3) compared to non-urgent bae (45.9%; n ¼ 17) (p ¼.04).Rebleeding tended to occurr earlier in non-urgent bae, being at 6-months (32.5%) and 36 months (41.3%) (p ¼.05).Ogib related 30-day mortality was 5.4% (n ¼ 2) for non-urgent bae and 0% for urgent bae (p ¼.5).Conclusion: urgent bae might be associated with higher dy and ty with lower rebleeding and trend toward higher rebleeding-free time.  type of adverse events/number of patients 1) event 1: death(30-day mortality) -2 patients.2) event 2: rebleeding -20 patients.It was concluded that rebleeding was lower in urgent balloon assisted enteroscopy (bae) when compared to non-urgent bae.Rebleeding occurred in 20 patients and median time to rebleed was eight weeks.A second bae was attempted and endoscopic treatment was performed.In the remaining cases medical treatment alone was undertaken.It was found that rebleeding was lower in urgent balloon assisted enteroscopy (bae) when compared to non-urgent bae. this literature article requires 2 reports.The related patient identifiers are as follows: 1) (b)(4).2) (b)(4).The 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

The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached 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 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.This supplemental report includes additional information provided by the author.B5 updated accordingly.Olympus will continue to monitor field performance for this device.

Event Description

The following additional information was provided by the author: the results presented in the article are not related to the devices used in the procedures.Mortality and bleeding were related to the patients' underlying pathology and not to complications arising from them.

• Brand Name: EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE
• Type of Device: SMALL INTESTINAL 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: 18426436
• MDR Text Key: 331865432
• Report Number: 9610595-2024-00031
• Device Sequence Number: 1
• Product Code: FDA
• UDI-Device Identifier: 04953170339943
• UDI-Public: 04953170339943
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K071254
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SIF-Q180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/19/2024
• 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