MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN EXTRACTION BALLOON V

Model Number	B-V443Q-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of our investigation, olympus followed up with the user facility to obtain additional information regarding the reported event but with no result.The subject device was not returned to the service center for evaluation.The exact cause of the reported event cannot be determined.However, the b-v443q-a and b-v243q-a instruction manual states ¿ before use, prepare and inspect the instrument as instructed below.Should the slightest irregularity be suspected, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient or user safety, pose an infection control risk, tissue irritation, perforation, bleeding, mucous membrane damage, and may result in more severe equipment damage.Never use excessive force to operate the instrument.This could damage the instrument.¿.
Event or Problem Description
The service center was informed that during an therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure, a total of four balloons broke in the patient.The balloons used were from three different lots.It is unknown if any device fragment fell into the patient.The intended procedure was completed.There was no patient injury reported.This is 2 of 4 reports.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The legal manufacturer reviewed the contents of this complaint.The legal manufacturer reported that the exact cause of the problem could not be conclusively identified, since the device was not retuned for the investigation.No abnormalities were found in the manufacturing record.Therefore, the phenomenon which was pointed out could not be confirmed.The legal manufacturer inspects the inflation of each product thoroughly to assure the quality of our products before shipping.There were no abnormalities or deformities such as leading to improper inflation of the balloons.Therefore, a likely cause of the hole in the balloon might be the following reasons.It is likely that the balloon popped because it was damaged by stone edges when inflated during stone retrieval.The device history records below were reviewed for the lot.The review revealed the lot had passed all the event-related inspection items.When the contents of the instruction manual (drawing number gk7054, revision number 8) were checked, the following description related to this event was made.Do not operate the instrument abruptly or with excessive force when retrieving a foreign object.Otherwise, patient injury such as bleeding, mucous membrane damage, or edema may occur.

• Brand Name: SINGLE USE 3-LUMEN EXTRACTION BALLOON V
• Common Device Name: SINGLE USE 3-LUMEN EXTRACTION BALLOON
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9207661
• Report Number: 8010047-2019-03646
• Device Sequence Number: 3146456
• Product Code: FGE
• UDI-Device Identifier: 04953170368769
• UDI-Public: 04953170368769
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2020

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
• Operator of Device: Health Professional
• Device Model Number: B-V443Q-A
• Device Lot Number: 81YZ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1