MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CHOLEDOCHOFIBERSCOPE; CHOLEDOCHO FIBERSCOPE

Model Number CHF-XP20

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp (omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.

Event Description

Olympus medical systems corp.(omsc) received a literature titled ¿usefulness of a transcutaneous approach for intrahepatic stone disease after biliary reconstruction¿.The literature reported the result of 49 cases of the percutaneous transhepatic biliary drainage (ptbd) procedures using olympus choledochofiberscope model chf-t20 and chf-xp20 and bronchovideoscope gf-260 from 1995 to 2018.In the subject cases, 7 cases of cholangitis and 2 cases of biliary tract bleeding occurred.Based on the available information, a direct relationship between the olympus products and the observed adverse events could not be determined.Therefore, omsc will submit 27 medical device reports depending on the number of adverse events.This report is 16 of 27 reports for cholangitis at chf-xp20.

• Brand Name: OES CHOLEDOCHOFIBERSCOPE
• Type of Device: CHOLEDOCHO FIBERSCOPE
• 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: 9456676
• MDR Text Key: 186538826
• Report Number: 8010047-2019-04272
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K843084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2019

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: Health Professional
• Device Model Number: CHF-XP20
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/12/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other