MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE BALLOON DILATOR V (WITH KNIFE)

Model Number UNKNOWN

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).The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) received a literature titled ¿long-term outcomes of endoscopic papillary large-balloon dilation for common bile duct stones¿.The literature reported the result of 98 cases of the endoscopic papillary large balloon dilation (eplbd) procedure for patients with common bile duct stones (cbd) using olympus videoscope model jf-260v or tjf-260v or gif-xk240 or sif-q260 and 5.5-fr cannula and stonemaster v from october 2011 to december 2015.In the subject cases, 1 case of perforation, 3 cases of acute cholangitis and 5 cases of acute cholecystitis occurred.Perforation occurred in the procedure using gif-xk240 or sif-q260.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 6 medical device reports (mdr) depending on the type of device and type of adverse events.This report is 5 of 6 reports for acute cholangitis at stonemaster v.

• Brand Name: SINGLE USE BALLOON DILATOR V (WITH KNIFE)
• Type of Device: BALLOON DILATOR
• 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: 10031881
• MDR Text Key: 190106900
• Report Number: 8010047-2020-02536
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other