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

Model Number GF-UCT260

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

Patient Problem No Code Available (3191)

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 30, 2020, olympus medical systems corp.(omsc) received literature titled "infected pancreatic necrosis mimicking pancreatic cancer".This study was conducted endoscopic ultrasound-guided fine-needle aspiration (eus-fna) for pathological diagnosis on a (b)(6) years old man who suspected pancreatic cancer.In the literature, it was reported that canceled the eus-fna procedure due to a rupture of the peripancreatic area, and the patient was closely monitored.Before the eus-fna procedure, the mass of the body of the pancreas was irregular in shape, and the margin was unclear.The pus-like fluid was aspirated from the tissue by eus-fna.However, the abscess of the pancreatic body lesion was ruptured to the peripancreatic area just after eus-fna.The patient was closely monitored for intravenous antibiotic treatment.Based on the available information, detailed information of the subject device was not provided, and there is no description of the relationship between the events and the subject device.However, omsc assumes that canceled the eus-fna procedure due to ruptured to the peripancreatic area might be related to the subject device since the subject device was used for the eus-fna procedure.Therefore omsc assumes that the event might be a reportable serious injury.There is no description of the device's malfunction.Omsc will submit one medical device report (mdr) for the event.

• Brand Name: EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE
• 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: 10980762
• MDR Text Key: 220757335
• Report Number: 8010047-2020-10138
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: GF-UCT260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/09/2020
• 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): Hospitalization
• Patient Age: 67 YR