MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-Q260J

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001); Pneumonia (2011)

Event Date 02/22/2022

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: "original article effects of steroid use for stenosis prevention after endoscopic submucosal dissection for cervical esophageal cancer."     literature summary: esophageal stenosis is a serious complication after endoscopic submucosal dissection (esd) for thoracic esophageal cancer (tec), and steroid has been applied for stenosis prevention.However, the rate of stenosis and effect of steroid for esd of cervical esophageal cancer (cec) remain unknown.The aim was to clarify the rate and managements of post-esd stenosis for cec.    type of adverse events/number of patients: muscle injury during esd in tec group -(14).Post esd bleeding - (2).Perforation - (9).Post esd stricture - (24).Aspiration pneumonia - (2).Additional treatment after esd (surgery - 10, crt - 9).This article includes 3 reports: (b)(6) : gif-q260j.(b)(6) : gif-h290t.(b)(6) : kd-655l.This report is 1 of 3 for (b)(6) : gif-q260j.

Event Description

The author responded to our request for additional information.The author did not have the model serial or lot numbers available.The author confirmed no malfunctions occurred with olympus devices.In the opinion of the author, the olympus device did not cause or contribute to the reported adverse events.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the author and the legal manufacturer's investigation.New information added to the following fields: h6, h10.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.

• Brand Name: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL 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: 14789586
• MDR Text Key: 295040418
• Report Number: 8010047-2022-10679
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K954451
• 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: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• 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
• Date Manufacturer Received: 06/26/2022
• 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
• Treatment: KD-655L, UNKNOWN LOT.
• Patient Outcome(s): Other