MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SPRAY CATHETER

Model Number PW-6C-1

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

Patient Problems Fever (1858); Paresis (1998); Pneumonia (2011)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.

Event Description

On november 16, 2020, olympus medical systems corp.(omsc) received the literature titled "safety and reproducibility of virtual-assisted lung mapping: a multicentre study in (b)(6)".This study was conducted the virtual-assisted lung mapping (val-map) as a preoperative bronchoscopic multi-spot dye-marking technique on 500 patients between (b)(6) 2012 and (b)(6) 2016.The vap-map was used by the subject device.In the literature, it was reported that 18 cases of pneumothorax,6 cases of pneumomediastinum, and 6 cases of alveolar hemorrhage have occurred as minor complications.And 4 patients were reported major complications that needed additional medical management, including fever necessitating the postponement of surgery (2 patients), pneumonia, and self-limited hemiplegia attributable to underlying cerebrovascular disease.It was reported these complications are associated with val-map.Based on the available information, detailed information of the subject device was not provided.Therefore, omsc assumes that the 4 cases of major complications needed additional medical management might be related to the subject device since the subject device was used for the vap-map.There is no description of the device's malfunction.Omsc will submit one medical device report (mdr) for the event type of the major complications needed additional medical management.

• Brand Name: SPRAY CATHETER
• Type of Device: SPRAY CATHETER
• 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: 10901724
• MDR Text Key: 218499154
• Report Number: 8010047-2020-09431
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PW-6C-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2020
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention