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

Model Number JF-260V

Device Problem Device Fell (4014)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/17/2019

Event Type  Injury  

Manufacturer Narrative

The subject device has not returned to olympus medical systems corp.(omsc).The facility reported that the clip was used to another patient, who suffered from an infection (hbv+) before being used in the subject patient.After the procedure, the olympus representative visited the facility, and they checked the subject device but found no abnormalities.Omsc reviewed the manufacturing history(dhr) of the subject device and confirmed no irregularity.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 was informed that during endoscopic retrograde cholangiopancreatography(ercp) using the subject device, the facility noticed that an unspecified clip came out from the subject device and fell off into the patient.The facility reported that they could not retrieve the clip from the patient.The clip has remained in the patient's body.The subject device had been brushed manually using a non-olympus cleaning brush (abis, ref:(b)(4) ) and reprocessed using an olympus automated endoscope reprocessor model oer-4(not available in the usa).There was no report of patient infection associated with this report.

• 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: 8862658
• MDR Text Key: 153347051
• Report Number: 8010047-2019-02840
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/05/2019

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2013
• 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 Outcome(s): Other