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

Model Number GF-UCT260

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/09/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device is planned to be returned to olympus but has not been returned to olympus yet.Olympus obtained additional information from the reporting person as following: it was probably that the blood came out from the air/water nozzle from the picture taken by the user facility; the inspection and reprocess after use were performed according to the instructions; the previous procedure was unspecified, but the procedure had lots of bleeding; the subject device had been reprocessed with an olympus automated endoscope reprocessor model oer-3 (not available in the usa); it was confirmed that the air/water feeding by the air/water nozzle and balloon channel could be performed for 10 seconds; the cleaning of the basic, inside the forceps elevator (using mh-974) and each channel (using bw-20t, bw-400l, maj-1534) were performed appropriative according to the instructions; it was probably the same day that the reprocessed day and the event day; the blood was confirmed when it was taken out of the storage; the user facility said it was probably that when the solidified blood was put in the automated endoscope reprocessor, it melted and dripped from the air/water nozzle due to gravity.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during preparation for use, it was found that blood came out from the nozzle.The user didn't use the subject device because the user could not completely removed it even if washing several times.There was no report of patient injury associated with the event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information and the subject device evaluation result.The subject device was returned to olympus medical systems corp.(omsc) for investigation.Olympus obtained additional information from the reporting person as followings.The reprocessing was on the same day as the procedure, but it seems that there was a whole day until the blood was found.The user reprocessed normally at first reprocessing because the blood was not found at the inspection of the immediately after the procedure and that was not correspond the ¿presoak for excessive bleeding and/or delayed reprocessing after each procedure¿ that was said the instruction for use.The user said that the second and subsequent reprocessing were performed only by oer-3.The user said that the blood adhesion was found already during preparation for use.The user said that the blood was not found during the inspection of the immediately after the procedure.There was no malfunction on the exterior of the cleaning tube.Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity.Omsc checked the subject device and found that the reported phenomenon (foreign material such as blood was clogged in the nozzle for about 35 cm) was duplicated.Based upon the investigation, omsc concluded that the reported phenomenon was attributed to the liquid that flowed back into the air/water nozzle during the procedure could not be removed when the reprocessing.The mechanism of the event is followings.During the procedure, the blood and the body fluid flowed back into the nozzle of the subject device.The blood and the body fluid that has flowed back into the nozzle has coagulated and clogged.The nozzle where blood and body fluids coagulated and clogged could not be completely cleaned in the reprocessing.Although the clogging in the nozzle was not completely cleaned, air bubbles and water supply from the distal end could be confirmed during the preparation for use (even if water is being supplied, air bubbles may appear for the first few seconds.) before the procedure, the body fluid in the nozzle was discharged as a foreign material from the nozzle.

• 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: 11608257
• MDR Text Key: 268817243
• Report Number: 8010047-2021-04517
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UCT260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2018
• 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