MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BALLOON

Model Number	MAJ-1351
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to be returned to the service center therefore, the exact cause for the reported event cannot be determined.
Event or Problem Description
The service center received a report of a maj-1351 balloon-bf-uc, lot 95k, that burst and fragmented into at least two pieces internally, in a patient, during a diagnostic endobronchial ultrasound.The maj-1351 balloon was inspected prior to the procedure and was noted to be functioning normally.The balloon was inflated with sterile saline solution.The device was inflated to improve the ultrasound image, then deflated for removal of the scope from the et tube.The balloon was noted to be missing after removal of the scope from patient¿s et tube.It was reported that it appeared that the balloon seemed to burst, as the scope was being withdrawn through the et tube adaptor.A small piece of the balloon was discovered at the top of the et tube just inside the adaptor, no other pieces were evident.All airway passages were thoroughly examined with a bronchoscope after discovery and no other fragments were located.It was reported that the balloon fragment was retrieved by the physician using forceps.No bleeding was reported.It is unknown if the procedure was completed.It was reported there was no additional medical treatment, prolonged observation or hospitalization provided to the patient due to the reported event.There was no apparent adverse effect to the patient and he was discharged from outpatient area without apparent problem.It was reported the device is not available for return.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of a device history record (dhr) review performed by the oem.Update: h6.The dhr was reviewed by the oem and no anomalies were noted in the production of the affected lot number.

• Brand Name: BALLOON
• Common Device Name: BALLOON
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9555493
• Report Number: 8010047-2020-00807
• Device Sequence Number: 16892409
• Product Code: PSV
• UDI-Device Identifier: 04953170175619
• UDI-Public: 04953170175619
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K042140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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: MAJ-1351
• Device Lot Number: 95K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 86