MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BIOPSY VALVE

Model Number	MB-358
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
Event or Problem Description
During the endoscopic retrograde cholangiopancreatography (ercp), the part inside the forceps cap fell off into the patient's body.The user collected the dropped part.The user replaced the device with a similar device and completed the procedure.There were no reports of patient injuries related to this incident.The user facility did not provide other detailed information.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined.However, based upon the investigation result there was the possibility that the reported phenomenon was attributed to the following occurrence mechanism.Syringe was used in a sharp state due to the irregularity (crack, chip, bending, dent, etc.) at the tip of the syringe which connected to the subject device (mb-358).Therefore, the part inside the subject device fell off.

• Brand Name: BIOPSY VALVE
• Common Device Name: BIOPSY VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10940158
• Report Number: 8010047-2020-09781
• Device Sequence Number: 11307162
• Product Code: FDS
• UDI-Device Identifier: 04953170063947
• UDI-Public: 04953170063947
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: MB-358
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1