MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP.; ULTRASOUND GASTROVIDEOSCOPE

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

Patient Problem Unspecified Infection (1930)

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 lot 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 was no description of the device's malfunction.

Event Description

On november 2, 2020, olympus medical systems corp.(omsc) received literature titled "endoscopic ultrasound-guided fine-needle aspiration skill acquisition of gastrointestinal submucosal tumor by trainee endoscopists: a pilot study".The purpose was to assess the skill acquisition and diagnostic accuracy of endoscopic ultrasound-guided fine-needle aspiration (eus-fna) for gastrointestinal smt in trainee endoscopists in order to elucidate the optimal starting standards of eus-fna.In the literature, it was reported that 2 infections required each rehospitalization after eus-fna were observed in 51 patients with gastrointestinal submucosal tumors underwent eus-fna from (b)(6) 2010 to (b)(6) 2014 at the (b)(6) hospital.The author wrote, "although infections occurred in two cases (3.9%), which were managed conservatively, no severe complications were identified¿, and also according the discussion ¿our study showed that two infections occurred.We presume that it is not due to technical issues but because of the nature of the lesions.¿ it was reported about the detail as bellow according to the result: infection after eus-fna occurred in two patients.One was esophageal smt diagnosed as a duplication cyst by eus-fna and the other was gastric smt diagnosed as gist by eus-fna.The first lesion was identified as a well-defined, homogenous, hypoechoic mass adjacent to the esophagus by eus and a 3-cm unenhanced mass to the left of the abdominal esophagus by computed tomography (ct).An esophageal submucosal tumor was suspected; however, the cystic nature of the lesion was not diagnosed due to the solid-tissue appearance of the lesion presumably because of the mucinous nature of the fluid, and the typical wall-layers were not appreciated.Both patients were discharged without complications on the third day after eus-fna.They were admitted to the hospital on the fourth day and eighth day after the eus-fna and were managed conservatively with antibiotic therapy and with antibiotics and percutaneous transhepatic abscess drainage, respectively.Technical complications, such as intestinal perforation or hemorrhage, were not identified during the follow-up periods.The eus-fna procedures were performed using an endoscopy (gf-uct240-al5 or gf-uct260; olympus).Omsc will submit 1 medical device report (mdr) of evis lucera ultrasound gastrovideoscope for 2 infections required each rehospitalization after eus-fna.

• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• 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: 10841932
• MDR Text Key: 218497803
• Report Number: 8010047-2020-08961
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization