MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION SINGLE USE 3-LUMEN EXTRACTION BALLOON V

Model Number B-V233P.A

Device Problem Use of Device Problem (1670)

Patient Problem Internal Organ Perforation (1987)

Event Date 08/19/2015

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the patient's outcome could not be conclusively determined at this time.The instruction manual warns users: "do not force the distal end of the insertion portion against body cavity tissue.This could result in perforation, bleeding, or mucous membrane damage." if additional information becomes available at a later time, this report will be supplemented.

Event Description

Olympus was informed that during an endoscopic retrograde cholangiopancreatogram (ercp) procedure, the patient sustained a small perforation.It was reported that the physician felt the tip of the device was hard and sharp, and the perforation was noted the duct was cannulated.The perforation was sealed by the physician during the same procedure.It is unknown what device was used to complete the procedure.The device referenced in this report was discarded by the user facility.No further information was provided.Olympus followed up with the user facility to obtain additional information regarding the reported event via telephone and in writing, but with no further results.

• Brand Name: SINGLE USE 3-LUMEN EXTRACTION BALLOON V
• Type of Device: SINGLE USE 3-LUMEN EXTRACTION BALLOON V
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho,; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 5054494
• MDR Text Key: 24988576
• Report Number: 2951238-2015-00417
• Device Sequence Number: 1
• Product Code: LQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B-V233P.A
• Device Catalogue Number: B-V233P.A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention