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

Model Number GIF-Q260J

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

Patient Problems Chest Pain (1776); Fever (1858); Nausea (1970); Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/23/2022

Event Type  Injury  

Event Description

Olympus medical systems corp.(omsc) received a literature titled "endoscopic closure of refractory upper gi¿tracheobronchial fistulas with a novel occluder: a prospective, single-arm, single-center study (with video)." this prospective, single-arm, single-center trial assessed the efficacy and safety of endoscopic closure with this novel occluder in patients with refractory upper gi¿tracheobronchial fistulas.A total of 28 patients with a mean age of 63.2 ± 7.7 years were enrolled.Eighteen ttsos (64.3%) and 10 ttoos (35.7%) were implanted with 100% technical success in all 28 cases.There were no significant differences in operation time.However, the mean occluder placement time of the ttoos (defined as the time between over-tube insertion and withdrawal) was significantly longer than that of the ttsos (defined as the time between implanter insertion and withdrawal; 6.8 ± 4.2 minutes vs 3.1 ± 1.2 minutes, respectively; p =.017).At 6 months, the csr of the remaining 25 patients was 92.0% (23/25), with a ccr of 60.0% (15/25) and ncr of 32.0% (8/25).The receiver-operating characteristic curve of fistula size for predicting complete closure at 1 month (area under the curve,.730; 95% confidence interval,.531-.929) demonstrated the cutoff value to be 8.5 mm with a sensitivity of 63.6% and specificity of 82.4%.In conclusion, the gi occluder is a feasible, effective, and safe modality for endoscopic closure of refractory upper gi¿tracheobronchial fistulas, and the implanting procedure is easy and convenient.Type of adverse events/number of patients: death (bone metastasis) - 1 patient.Death (peritoneal metastasis) - 1 patient.Abscission of the occluder - number of patients not reported.Intolerable cough - 1 patient.Expanded fistula - 1 patient.Mild foreign body sensation - 5 patients.Transient postprocedural fever - 4 patients.Transient dull chest pain - 2 patients.Transient nausea - 1 patient.Occluder migration - 1 patient.One patient died of peritoneal metastasis at 11 months follow-up, and one patient died of bone metastases.According to the literature text, there were no device-related or procedure-related deaths.One patient had an esophagobronchial fistula device removed endoscopically due to an intolerable cough there is no report of any olympus device malfunction in any procedure described in this study.This literature article requires 2 reports for serious adverse event (intolerable cough).The patient identifiers are: (b)(6): gif-q260j, (b)(6): bf-1t260.This report is for (b)(6).

Manufacturer Narrative

H6: appropriate term: mild foreign body sensation.The literature described "gif-q260j or gif-xp260", but since both are evis lucera upper gastrointestinal videoscopes, olympus selected "gif-q260j" as the representative model.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

Olympus further received information that there was no olympus device malfunction and no adverse event occurred that an olympus device has caused or contributed in the literature.

Manufacturer Narrative

This report is being supplemented to provide additional information received from the author.

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 a correction to g2 to provide information that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• 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: 17788277
• MDR Text Key: 323919490
• Report Number: 9610595-2023-13760
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/06/2023

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-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: 08/28/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 09/24/2023; 10/03/2023
• Supplement Dates FDA Received: 09/29/2023; 10/06/2023
• 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