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

Model Number	B-V433P-A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has yet to be returned to the manufacturer for evaluation.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if the device is returned for evaluation and/or additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
An olympus sales representative reported that a balloon ruptured during a procedure and the physician had to extract the balloon.The event occurred during the initial use of the device.There was no patient harm or injury reported.
Additional Manufacturer Narrative
This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: d10, g4, h2, h6 and h10.As part of the investigation, olympus followed up with the user facility to obtain additional information but with no results.Although the lot number is unknown, the investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The legal manufacturer determined that reportable malfunction was likely due to damage by stone edges when inflated during stone retrieval.As stated on the ifu and as a preventive measure, the user manual states: 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.Olympus will continue to monitor complaints for this device.

• 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: 10987270
• Report Number: 8010047-2020-10195
• Device Sequence Number: 19011778
• Product Code: FGE
• UDI-Device Identifier: 04953170275746
• UDI-Public: 04953170275746
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K091495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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-V433P-A
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1