MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA PLEURA VIDEOSCOPE; FLEX DEFLECTABLE VIDEOSCOPE

Model Number LTF-160

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Respiratory Problem (4464)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

Olympus reviewed the following literature: "bedside pleuroscopy in the intensive care unit" by hean ooi.This study retrospectively analyzed the data from a consecutive case series, and examined the complications and outcomes following bedside pleuroscopy in patients with undiagnosed pleural effusion with acute respiratory failure.A total of 25 patients underwent pleuroscopic procedures at the bedside, and were routinely monitored and recorded for any major and minor complications.The study reported that fifteen patients (60%) had malignancies, of whom 11 had lung cancer, and one each had breast cancer, esophageal cancer, hepatoma, and a malignant mediastinal tumor.A total of 11 (44%) patients suffered any complications, but no major complications were reported.The study concluded that the pleuroscopy performed at the bedside in an icu with local analgesia was an easy and well-tolerated procedure, and could be used for patients in critical condition.Type of adverse events/number of patients: subcutaneous emphysema - (3): all patients had 16 f pig-tail catheter drains after the procedure through the same entry port as the pleuroscopy to avoid the spread of subcutaneous emphysema.Hypotension (periprocedure) - (1): noted during the procedure was also correctable with adequate hydration.This article includes 2 reports: patient identifier (b)(6): ltf-160.Patient identifier (b)(6): ltf-240.This report is 1 of 2 for patient identifier (b)(6): ltf-160.

Manufacturer Narrative

Event date updated to reflect online publication date of source article.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 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.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA PLEURA VIDEOSCOPE
• Type of Device: FLEX DEFLECTABLE VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14073644
• MDR Text Key: 294496355
• Report Number: 8010047-2022-06030
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 04953170340284
• UDI-Public: 04953170340284
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K013617
• 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: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LTF-160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2022
• 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