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

Model Number JF-260V

Device Problems Device Contamination with Chemical or Other Material (2944); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to omsc for evaluation.Omsc checked the subject device and found that there was no abnormality such as foreign material adhesion or kinking inside the subject device, including the instrument channel, suction channel, instrument channel port, branching of channels and inside cylinder and also found that there were no significant exterior defect on the subject device.Therefore omsc concluded that there was no failure which was caused by the remaining the stent in the subject device.Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based upon the reported information and the investigation result of the subject device, omsc surmised that the reported phenomenon might be attributed to insufficient brushing in the channels.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the treatment of the patient with common bile duct stones using the subject device, when a crushed stone basket was inserted into the subject device, it was confirmed that a fragment of the metallic stent came out from the distal end of the subject device and fell into the patient¿s body.The intended treatment was completed using the subject device without any problems, but since the fragments of metallic stents rolled to the horizontal side of the duodenum in the patient and could not be removed from the patient¿s body.After that, as a result of the blood test by the user, it was confirmed that there was no infection on the patient.In addition, the user sated that the metallic stent that had fallen off in the patient's body was a stent that was used in combination with the product in another procedure performed on (b)(6) 2021 (century niti-s bile duct s-type 6 mm x 12 cm full covered), and the details are as follows.There was another patient who originally had a metallic stent and a plastic stent in it due to malignant stenosis of the bile duct.Since the plastic stent was clogged, a replacement procedure was performed.When the user tried to remove the clogged plastic stent, the flap on the hepatic portal side got caught in the cell of the metallic stent and could not be removed, the plastic stent stretched, and a part of the papillary side of the metallic stent stretched and torn off.(at that time, the food residue was so bad that the user didn't know if the torn metallic stent fragments had fallen off.) after that, the user managed to remove the plastic stent and placed the endoscopic nasobiliary drainage (enbd) tube was placed and completed.The reprocessing of the subject device was carried out as usual there was no report of patient injury associated with this event.

• Brand Name: EVIS LUCERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• 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: 12878074
• MDR Text Key: 285941829
• Report Number: 8010047-2021-15117
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2005
• 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 Age: 92 YR
• Patient Sex: Female