MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BALLOON

Model Number	MAJ-1351
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Olympus medical systems corp.(omsc) could not investigate the subject device, because the subject device was not returned to omsc.Omsc reviewed the manufacturing record and found no irregularities.Also, omsc checked the complaints of the maj-1351 which had same lot number as subject device whether there was the similar complaint as this phenomenon, there was no similar complaint.The exact cause of the phenomenon could not be determined.However, it was likely the reported phenomenon was caused by following handlings; the user could not attach the subject device to the endoscope correctly.The user did not lubricate the subject device before insertion the insertion of the endoscope into the patient.The instruction manual of the endoscope which is used combination with the subject device states the appropriate handling of the subject device including the procedure of attaching the subject device and the using the lubricant.
Event or Problem Description
During the unspecified procedure with the bf-uc190f with attaching the subject device, the subject device fell off from the bf-uc190f into the patient's respiratory tract.The user retrieved the subject device from the patient using with the unspecified forceps.The user discarded the subject device accidentally.There was no report of patient injury associated with this event.There was no report other than above.

• 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: 9509064
• Report Number: 8010047-2019-04538
• Device Sequence Number: 14127041
• Product Code: PSV
• UDI-Device Identifier: 04953170175619
• UDI-Public: 04953170175619
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/23/2019

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: No Information
• Device Model Number: MAJ-1351
• Device Lot Number: 71K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1