MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS PLEURA VIDEOSCOPE; FLEX DEFLECTABLE VIDEOSCOPE

Model Number LTF-240

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

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 03/07/2022

Event Type  Injury  

Event Description

It is reported in the literature titled ¿efficacy, safety, and optimal timing of single-trocar video-assisted flexible thoracoscopic debridement under local anesthesia for complicated parapneumonic empyema¿¿ patients experienced adverse events after procedures using pleura videoscopes.Case with patient identifier (b)(6) reports evis pleura videoscopes.Case with patient identifier (b)(6) reports evis lucera pleura videoscopes.Objective: thoracoscopic debridement under local anesthesia is a useful approach for complicated parapneumonic effusion or empyema (cpe) and is a less invasive procedure than video-assisted thoracoscopic surgery under general anesthesia.There are various methods of thoracoscopic debridement under local anesthesia, although the optimal timing of treatment is unknown.The objective of this study was to verify the efficacy and safety of our video-assisted flexible thoracoscopic debridement (vafts-d) procedure under local anesthesia, and to investigate the clinical features associated with the success of vafts-d.Methods: the study included 71 consecutive patients with cpe who underwent vafts-d.The primary outcome was success of vafts-d.We retrospectively analyzed the efficacy and safety of vafts-d from the clinical data obtained from hospital medical records and used univariate logistic analyses to identify potential predictors of the outcome.Results: vafts-d was considered successful in 62 of 71 patients (87.3%).Two of the remaining nine patients died and the other seven patients required subsequent operation under general anesthesia.Complications due to vafts-d occurred in six patients (8.5%).Duration of empyem<10 days (p=0.024) and negative bacterial culture in pleural effusion (p=0.029) were independently associated with the success of vafts-d by univariate logistic regression analysis.Conclusion: vafts-d might be an acceptable first-line procedure in patients with suspected cpe.Vafts-d should be performed as early as possible for a successful outcome, and to obtain useful information on the pleural cavity.Complications due to vafts-d occurred in six patients (8.5%), including lung injury without persistent air leakage (n = 3), acute respiratory distress syndrome (n = 2), and port insertion into the abdominal cavity (n=1).The injury occurred during port insertion in all three patients with lung injury.However, bleeding from the lung parenchyma stopped spontaneously, and air leakage was not observed after vafts-d.Both cases who developed acute respiratory distress syndrome improved within a few days after vaftsd, although one case required mechanical ventilation and the other was managed with non-invasive positive pressure ventilation.There is no report of olympus device malfunction in any procedure described in this literature.

Manufacturer Narrative

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

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

• Brand Name: EVIS PLEURA VIDEOSCOPE
• Type of Device: FLEX DEFLECTABLE VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15216587
• MDR Text Key: 297776541
• Report Number: 9610595-2022-00828
• Device Sequence Number: 1
• Product Code: EWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013617
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LTF-240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2022
• 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