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

Model Number CHF-P20

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

Olympus has obtained additional information that the user facility normally uses the 3 mm scope but it was being repaired, so the user facility used the subject device which has 4.9 mm outer diameter at the distal end with a 5 mm cannula.An available next larger size of cannula was 12 mm and reportedly it would be too large for the procedure.The device referenced in this report has not been returned to olympus medical systems corp.But returned to olympus keymed (okm) for investigation.The investigation found that there was mechanical damage and water leakage.The outer layer in the insertion unit of the subject device was found to be detached from the inner tube mechanism and folded.The manufacturing record of the subject device was reviewed with no irregularity related to the phenomenon.The subject device was last serviced on (b)(6) 2016, and the insertion unit was replaced.The exact cause of the event could not be concluded at this moment but possibility the following could not be ruled out as a contributory factor of the event: concurrent use of a cannula that could not keep sufficient clearance with the subject device.If additional and significant information becomes available, this report will be supplemented.

Event Description

The subject device was used for a laparoscopic common bile duct examination.The user facility reported that the damage in insertion unit of the subject device that has 4.9 mm outer diameter, was observed upon withdrawal and the damage may have occurred as a result of using a cannula which has 5 mm inner diameter.The user facility also reported that a portion of plastic came off in the patient¿s abdominal cavity but it was removed.The intended procedure has been completed.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: OES CHOLEDOCHOFIBERSCOPE
• Type of Device: CHOLEDOCHO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 8142642517
• MDR Report Key: 6394186
• MDR Text Key: 69879620
• Report Number: 8010047-2017-00277
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK843084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

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: CHF-P20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2007
• 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